Life Science Webinars
Upcoming Webinars
Welcome to the life science webinar program. Our subject matter experts cover many subjects, ranging from biopharmaceutical manufacturing to biology, chemistry, and water purification. From regulation, cell culture, and emerging technologies to laboratory trends & tips, our team of leading scientists is here to help. Join us for live conversations, panel discussions, and Q&A sessions, or listen to our on-demand webinars at your convenience.
Purity as a Priority: Optimizing Safety Measures for rAAV TherapiesSubcategory: Biopharm Services and SolutionsDuration: 1 hour Date: 7 November, 2024 Time: 7:00 am PST 10:00 am EST 4:00 pm CET In this webinar, you will learn:
Recombinant Adeno-associated virus (rAAV) vectors are increasingly utilized in in vivo gene therapy. However, the complexity of rAAV manufacturing introduces various process-related impurities. These impurities can pose considerable risks to patient safety if not adequately addressed. This webinar discusses the common process-related impurities encountered in rAAV vector production and outlines the analytical methodologies used to detect and quantify these residuals in the drug substance. This information is particularly valuable for rAAV sponsors seeking to mitigate risks associated with process-related impurities and to comply with regulatory expectations. Speaker: |
5th Annual Biotech Startup SymposiumSubcategory: Biopharm Services and SolutionsDuration: 2 hours Date: 13-14 November, 2024 Time: 7:00 am PST 10:00 am EST 4:00 pm CET Focus topics will include:
Join us at the 5th Annual Biotech Startup Symposium, a free, two-day event designed to help biotech startups accelerate their path to commercialization. Hear from industry experts as they dive into emerging technologies and the latest trends, offering insights and advice to help you unlock your molecule’s potential. Speakers: |
Artificial Intelligence-based Screening and Selection of Co-formers for Co-crystallizationSubcategory: FormulationDuration: 1 hour Date: 19 November, 2024 Time: 8:00 am EST 2:00 pm CET In this webinar, you will learn about:
70% of APIs under development are poorly water soluble which increases the risk of them failing during formulation. Co-crystallization is a rapidly growing technique used to tackle solubility challenges. However, it is challenging and resource intensive to find new co-crystals experimentally. In recent years several approaches have been developed to screen for co-crystals computationally. We developed mPredict™, a co-crystal prediction tool with quantum chemistry, statistical thermodynamics and AI. It predicts co-crystal formation and hence optimal co-formers for your API. Besides being a strong improvement over physical modelling, it is also three times faster than random digital screening. Speaker: |
Nitrosamines Risk Assessment: Role of ExcipientsSubcategory: RegulatoryDuration: 1 hour Date: 19 November, 2024 Time: 2:00 pm SGT 3:00 pm JST 11:30 am IST In this webinar, you will learn:
N-nitrosamines are classified as probable human carcinogens, necessitating that drug substance and drug product manufacturers implement measures to reduce or prevent nitrosamine impurities in APIs and drug products. This requires comprehensive risk assessments to evaluate nitrosamine levels and implement effective mitigation strategies. Several factors contribute to nitrosamine formation or contamination, including the presence of nitrites in excipients, which pose risks when combined with vulnerable amines during manufacturing and storage. This presentation will offer insights into nitrosamine impurities, updates on regulatory expectations, and the critical role of excipients in assessing nitrosamine risks in pharmaceutical products. Speaker: |
Ensuring Safe Bulk Liquid Transport with High Strength Single-Use AssembliesSubcategory: DownstreamDuration: 1 hour Date: 21 November, 2024 Time: 7:00 am PST 10:00 am EST 4:00 pm CET In this webinar, you will get:
Transportation in bioprocessing is essential for the safe and efficient delivery of critical materials. Single-use technologies are enhancing reliability and operational efficiency in this field. In this webinar, we will explore the key properties of a high-strength film used in single-use assemblies and their role in effective transportation management. We’ll provide an overview of relevant ISTA testing for transport qualification, detailing the completed tests for single-use assemblies with carriers. Finally, we’ll present a case study simulating difficult shipping conditions to highlight importance of film robustness in transport. Speakers: |
Webinars: On Demand
To begin, please select a category:
Analytics & Sample Preparation
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Subcategory: Chromatography |
New Column Modalities for Improved Biomolecule SeparationsSubcategory: ChromatographyThe purpose of this webinar is to discuss two column modalities that have now expanded their utility into the large molecule separations arena: monolithic silica columns and superficially porous particle (SPP) packed columns. Abstract: Selected aspects of the physical parameters of the stationary phase will be discussed in relation to improved efficiencies and throughput over traditional fully porous particle (FPP) packed columns. In addition, applications illustrating the relevance of these column modalities in regard to characterizing biomacromolecules and advantages of these column modalities over FPP packed columns will be presented and discussed. By attending this webinar you will learn:
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Solutions for Mass Spectrometry: Tips, Tricks and ApplicationsSubcategory: ChromatographyThe webinar covers tips and tricks for optimizing your coupling liquid chromatography with Mass Spectrometry including: General considerations, mobile phase quality and contamination, solvent storage, equipment cleaning, buffers, Column bleeding and washing. Sensitivity, column robustness and lifetime are discussed, using application examples in LC-MS. Additionally, how to correctly analyze dirty samples with LC-MS is explored. Speaker: |
Chromatographic Solutions to Improve Food SafetySubcategory: ChromatographyThe presentation will introduce strategies/solutions to improve food safety using different chromatographic techniques (sample preparation, HPLC/UHPLC, TLC/HPTLC). Scandals in recent years have clearly proven that better testing is required. Techniques have to be more selective, quicker and with higher sensitivity. The talk will discuss the analytical possibilities from a molecular perspective, thus how it is possible to develop a suitable method using the most appropriate analytical technique. The aim with the presentation is that the attendees afterwards will consider the molecule(s) first and choose the most suitable technique from that perspective. Speaker: |
Trouble-Free HPLC Analysis of Creams and Lotions: Beautiful Separations of Beauty ProductsSubcategory: ChromatographyIn this web seminar, we will demonstrate the benefits of using monolithic silica columns, illustrating those benefits with the numerous experimental data and detailed application examples on a variety of "creamy" sample types. Matrix rich samples such as creams, lotions and lipsticks present analytical challenges. Monolithic silica columns can be of great benefit when dealing with samples like these. In contrast to conventional particle-packed columns, monolithic silica columns are made of a continuous piece of high purity porous silica. High permeability and porosity of the silica skeleton and the resulting low backpressure allow for more flexible flow rates compared to particulate columns. This enables high throughput and robust analysis without loss of separation efficiency or peak capacity — even for relatively "dirty" samples. Speaker: |
Complete Solutions Regulated Pharmaceutical Instrumental AnalysisSubcategory: ChromatographyThis webinar is for anybody who is analysing pharma compounds and is interested in up-to-date information about the United States Pharmacopeia (USP) and National Formula (NF) including upcoming changes. Abstract: There are a number of important questions that must be considered when analyzing pharma compounds:
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Complete Solutions for Dissolution Testing - Monograph Methods for Tablets and CapsulesSubcategory: ChromatographyIn this webinar you will learn about dissolution testing using a few selected formulated small molecule drugs as examples. The application examples follow the current USP 37 - NF32 monographs and are all compliant with USP 38 - NF33 and the given suitability requirements. In addition to the application examples, the important role of filtration will be discussed in relation to dissolution testing, along with an examination of what changes are possible to the monograph methods. Dissolution testing is an integral part of the drug development lifecycle. The goals of dissolution testing change as the drug moves through the different stages of development. The effectiveness of different drug dosage forms relies on the drug dissolving in a predictable manner prior to absorption into the body. It is also important to optimize the drug's bioavailability over time and deviations from expected dissolution profiles mean that treatment could be either ineffective or dangerous to the patient. In this webinar you will learn:
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Coupling Thin Layer Chromatography to Mass Spectrometry: A combination of two powerful analytical methodsSubcategory: ChromatographyAttendees of the webinar will learn which instruments are available, how to ensure reliable results with the technique, and through the presentation of application examples, what additional value the technique can provide. The surge in interest of coupling thin layer chromatography (TLC) with mass spectrometry (MS) is due to the availability of commercial instruments that make the routine use of this technique possible. By coupling the advantages of TLC, such as the ability to separate many samples in parallel and the high matrix tolerance of this technique with MS, the TLC-MS becomes a powerful tool in the modern analytical environment. Speaker: |
Transfer of USP Methods from Particulate to Monolithic ColumnsSubcategory: ChromatographyThis webinar will focus on regulated chromatographic analysis and how methods can be transferred from one type of column to another with the same chemistry but with different backbones and physical properties. USP monograph methods, originally developed and validated for use with large particle HPLC columns, have been transferred and partially revalidated for use with monolithic columns. The examples in this webinar will be used to emphasis the new possibilities in changing HPLC methods per chapter 621 in United States Pharmacopeia. Speaker: |
SPME Method Development for Food AnalysisSubcategory: ChromatographyGiven that SPME is an environmentally friendly sample preparation technique, the interest towards its implementation to a variety of applications continues to increase. However, quite often SPME is not utilized to its full potential due to the lack of proper training. In this webinar, we will be focusing on the implementation of SPME methods for food analysis, including optimization of the factors affecting SPME efficiency; special considerations for targeted and non-targeted applications; quantitation in SPME; and novel SPME devices and future directions. What will you learn?
We will be providing the necessary tools for potential and current SPME users wishing to gain a deeper understanding into the SPME method and thus increasing their productivity. Who should attend?
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Subcategory: Classical Analysis |
Cleaner: How to Ensure Effective, Reliable and Safe Cleaning Procedures in Your LaboratorySubcategory: Classical AnalysisThis seminar illustrates characteristics of lab cleaning processes affected by regulations, standards and individual environments and requirements. It also covers essential application topics (e.g. validation procedures) and provides guidelines on how to carry out daily cleaning effectively, safely and with a focus on environmental protection. Abstract: Thorough, residue-free cleaning is essential for reliable processes. This applies to both laboratories and production facilities. Everything that comes into contact with chemicals or biological substances must be free of impurities, both before and after use. By attending this webinar you will learn: Participants will learn about specifics of applicable cleaning standards. Furthermore, ways to improve cleaning process effectiveness will be explored, with a view to helping you achieve reliable analytical results. In this seminar, detergent characteristics and practical guidelines (e.g. validation methods) will also be covered, as well as application examples for individual cleaning processes. Who Should Attend: Staff and managers of chemical labs (e.g. quality control, research). Speaker: |
Subcategory: Test Kits and Photometric Methods |
Beer analysis without the headache: Chemical and Microbiological Monitoring for BreweriesSubcategory: ChromatographyMonitoring a range of parameters such as bitterness, sulfite content, and spoilage contaminants throughout the beer making process ensures that you can produce safe, delicious, and high-quality beer. Sign up for our webinar where we will cover how to streamline both your chemical and microbiological analysis workflows. Chemical and microbiological monitoring for breweries:
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Drinking Water Monitoring and Ultra-sensitive Measurement of Iron in WaterSubcategory: Test Kits and Photometric MethodsWater and especially drinking or bottled water monitoring is of great importance: Besides health-hazard aspects for humans (for instance nitrate in drinking water) — it also includes sensory and technical reasons. The presentation focuses on the ultra-sensitive measurement of iron by an photometric method compared to ICP-MS analysis. You will learn more about monitoring of chemical parameters in drinking water with focus on an ultrasensitive photometric analysis for measuring iron in water. Speakers: |
Measuring Phosphate in Ground and Surface WaterSubcategory: Test Kits and Photometric MethodsThis event will provide scientists with updates on the latest issues faced by individuals working in these challenging analytical fields. Separation Science, in collaboration with MilliporeSigma has developed an online eSeminar focusing on the use and application of UV-vis spectrophotometry for the analysis of water. Taking place in a 1-hr session, this unique event will feaure technology experts and provide an interactive learning environment and online resource. Featured Speakers and Presentations: Sensitive and Reliable Measurement of ortho-Phosphate in Ground and Surface Water by Carolin Klein This presentation concentrates on a photometric method that can be used to detect ortho-phosphate levels as low as 2.5 µg/L. Examples demonstrated are surface water samples from lakes in Germany with their phosphate levels measured using photometry. This is an important application, because too high levels of phosphate may pose a risk to both human health and the environment. Analysing Phosphonates in Cooling and Boiler Water by Onur Akbulut Organic phosphonate salts are mainly used in industrial cooling and boiler water applications. As antiscalants and corrosion inhibitors, the main purpose of phosphonates (organic phosphorus) is to reduce scale and remove rust, and thus lower maintenance costs. For an efficient and smooth-running system, both dosing and monitoring the concentration of phosphonates(in circulation in the system), are crucial for boiler water. Therefore, accurate and sensitive determination of phosphonates is necessarily the cornerstone of laboratory analysis. Speakers: |
UV-vis Spectrophotometric Analysis of Water, Food, and BeveragesSubcategory: Test Kits and Photometric MethodsThis eSeminar focuses on the use and application of UV-vis spectrophotometry for the analysis of water, food, and beverages. Abstract: This one-day event will provide scientists with updates on the latest issues faced by individuals working in these challenging analytical fields. Taking place in one 2-hr session, this unique event will bring together a selection of technology experts and provide an interactive learning environment and online resource. Featured Presentations:
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Ultra-Sensitive Silicate Analysis in Process and Boiler WaterSubcategory: Test Kits and Photometric MethodsThe webinar will discuss photometric methods for analysis of silicate in boiler and process water using an ultrasensitive photometric technique. This technique is presented as an alternative to the graphite furnace atomic absorption technique. The webinar is aimed at anyone performing water analysis on boiler and cooling water, and/or anyone interested in silicate analyses. By attending this webinar you will learn:
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Subcategory: Titration |
Best Practices in Karl Fischer TitrationPrecise and accurate results of the determination of water contents are important for the quality of raw materials used in production processes and also for the finished products. The main challenge is how to produce reliable and comparable results by choosing the right application method, instrument and reagents for your Karl Fischer Titration. What Does it Cover? Precise and accurate results of the determination of water contents are important for the quality of raw materials used in production processes and also for the finished products. The main challenge is how to produce reliable and comparable results by choosing the right application method, instrument and reagents for your Karl Fischer Titration. What Will You Learn?
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Industrial Microbiology
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Subcategory: Sterile Membrane Filtration |
6 Impacts of Your Membrane Filtration Funnel Choice on Your WorkflowSubcategory: Sterile Membrane FiltrationDuration: 1 hour Date: 7 June, 2018 Sterile membrane filtration is the preferred microbiological method in most industries for filterable samples. Should you use reusable or single-used funnels? We will discuss the various factors that need to be considered when determining the type of funnel for your purposes. Speakers: |
Subcategory: Industrial Microbiology Misc. |
What you need to know about the new ISO 16140-3 on microbiological method verificationSubcategory: Industrial Microbiology Misc.Duration: 1 hour Date: 18 February, 2021 The webinar introduces the new EN ISO 16140-3 on the verification of methods in food microbiology. This standard provides the protocols and criteria to demonstrate that a user laboratory can satisfactorily perform a validated method and that this method is fit for its intended purpose. This webinar is intended for microbiological laboratory managers, technicians, and quality assurance teams. |
ISO 11133 Culture Media Quality Assurance: Latest Updates and Practical Lab TipsSubcategory: Industrial Microbiology Misc.Duration: 1 hour This webinar will give practical tips for daily handling of culture media including preparation, shelf-life testing, microbiological and physical performance testing amongst other topics. Abstract: ISO 11133:2014 is a mandatory standard for all ISO 17025-accredited labs for microbiological analysis of food, feed and water. It is also widely used by non-accredited labs. ISO 11133 and its latest amendments describes the preparation, production and performance testing of culture media from this whole area. Since its publication as a full ISO standard for food and water microbiology, it has been implemented in many labs, but still there are many open questions for the daily lab work. |
Short Talk: Compliant Detection and Enumeration of Campylobacter spp. in Food & Environmental SamplesSubcategory: Industrial Microbiology Misc.Duration: 20 minutes We will guide you through the testing workflow according to ISO 10272, FDA-BAM and USDA-FSIS, and show you how we make the regulatory compliance of our testing solutions transparent. Abstract: Campylobacter spp. is a leading human pathogen worldwide that causes the foodborne illness Campylobacteriosis. The testing workflow is regulated by international organizations to ensure consumer safety. But how can you stay compliant with these regulatory standards and ensure the most accurate results? Watch our 20-minute talk to learn about the foods and conditions that can cause Campylobacteriosis and the international standards that regulate the detection and enumeration of Campylobacter. Speaker: |
Short Talk: Detection of Listeria monocytogenes in Food and Environmental SamplesSubcategory: Industrial Microbiology Misc.Duration: 20 minutes 20-minute talk: detection of Listeria monocytogenes according to international standards Abstract: Listeria is a widespread microorganism in nature and Listeria monocytogenes is one of the most harmful pathogens which can cause serious foodborne illnesses and infections. It is therefore crucial to test food products and lab environments for Listeria monocytogenes. The testing workflow is regulated by international organizations to ensure consumer safety. But how can you stay compliant with these regulatory standards and ensure the most accurate results? We will walk you through the Listeria monocytogenes testing workflow according to ISO 11290, FDA-BAM and USDA-FSIS, and show you our solutions which will help you to stay compliant. Speaker: |
Monocyte Activation Test: A Powerful Tool to Assess Pyrogenic Risk in the Pharmaceutical ProcessSubcategory: Industrial Microbiology Misc.Duration: 24 minutes Presented: 9 April, 2019 The monocyte activation test performed with the PyroMAT™ System detects endotoxin and non-endotoxin pyrogens. Abstract: Microbial risk in pharmaceutical process is not limited to living microorganisms and intact microbial cells. Subcellular components from microorganisms remaining from the production process can be source of pyrogens, compromising product quality and patient safety as these substances are not eliminated by classical filtration or sterilization steps. Key topics include:
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Food Microbiology Regulatory Update: New & Revised ISO 11133 and ISO 17410 StandardsSubcategory: Industrial Microbiology Misc.Duration: 60 minutes Presented: 27 June, 2019 This webinar covers the latest news on ISO standards for culture media testing (ISO 11133), the enumeration of psychrotrophic microorganisms (ISO 17410) and an outlook for future new and revised ISO standards. Abstract: ISO 11133:2014+Amd1:2018 is a mandatory standard for all ISO 17025-accredited labs for microbiological analysis of food, feed and water. It describes the preparation, production and performance testing of culture media from this whole area. Planned publication of amendment 2:2019 contains the control strains for the performance testing of confirmation and characterization media, reagents, dyes, stains and materials described in standards for the microbiological examination of samples from the food chain and water. The technically revised edition of ISO 17410 specifies a horizontal method for the enumeration of psychrotrophic microorganisms that are able to grow at 6.5°C. It replaces ISO 6730:2005 (IDF 101:2005), "Milk — Enumeration of colony forming units of psychrotrophic microorganisms — Colony-count technique at 6.5°C" and ISO 8552:2004 (IDF 132:2004) "Milk — Estimation of psychrotrophic microorganisms — Colony count technique at 21°C (Rapid method)". This webinar explains the latest changes in ISO 11133 including its amendments and in ISO 17410 and will give an outlook on the future of these both standards and other ISO standards. Speakers: |
Short Webinar: Regulatory Compliance of Culture Media Based Detection of PathogensSubcategory: Industrial Microbiology Misc.Duration: 10 minutes This 10-minute talk focuses on ISO regulations for the detection of the most important pathogen, Salmonella spp., in the food chain and describes how the regulatory compliance for the required culture media can be made transparent for laboratories. Speaker: |
Environmental Monitoring in Aseptic Manufacturing - Regulatory Requirements for Culture Media and ValidationSubcategory: Industrial Microbiology Misc.Duration: 60 minutes Presented: 29 November, 2018 The webinar will cover the various GMP guidance, ISO Norms or pharmacopoeia regulatory demands for environmental monitoring culture media used in aseptic areas. Abstract: Environmental monitoring of air, surfaces and personnel in aseptic areas can be complex, particularly in terms of culture media and regulatory requirements including GMP, ISO norms and pharmacopoeia. Join our on-demand webinar to see how we can help guide you through. Topics covered include:
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Hygiene Monitoring Impact of Disinfectants on ATP resultsSubcategory: Industrial Microbiology Misc.Duration: 60 minutes Presented: 29 October, 2018 We provided a scientific comparison study, to see how different sample devices react to the main sanitizers used in Food and Beverage industry. Abstract: ATP testing is being used by many Food & Beverage companies to verify the efficiency of their cleaning procedure. The amount of ATP is measured by the bioluminescence reaction (luciferin + luciferase). Some chemical compounds, including detergents, can affect the light signal of this reaction. Therefore, the presence of disinfectant residues on surfaces can have a negative impact on the reading and lead to false negative results. We provided a scientific comparison study, to see how different sample devices react to the main sanitizers used in Food and Beverage industry. Other than that we will be pleased to introduce some projects our innovation center is working on:
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Spoilage and Sterility Tests in Beverages: New Revised IFU Method No. 12 for Detection of Alicyclobacillus in Fruit Juices, and Sterility Testing of Aseptic Filling LinesSubcategory: Industrial Microbiology Misc.Duration: 60 minutes Presented: 29 November, 2018 This webinar explains the new revised IFU Method No. 12 from 2019 for detection of Alicyclobacillus spp. in fruit juices and provides information about validation of aseptic filling lines in beverage production. Abstract: Alicyclobacillus spp. can be difficult to control in fruit juice products as their spores survive juice pasteurization temperatures and may germinate and grow after processing if conditions are suitable. The economic impact of such incidents can be very high. The International Fruit and Vegetable Juice Association (IFU) Microbiological Working Group has revised, improved and validated their worldwide accepted method for the detection of Alicyclobacillus spp. in fruit juices with improved culture media formulations including performance criteria which are in agreement with ISO procedures. For aseptic validation of filling lines, Sidel microbiological validations are carried out in two subsequent phases. The first takes place on Sidel premises to ensure the decontamination efficiency of the sterilization applied to packaging, while the second is carried out on the complete line installed at the customer site to ensure the commercial sterility of the filled product. Depending on the client's product, different microbiological broths for low acid (pH > 4.6) or high acid (pH ≤ 4.6) applications are useful. Speakers: |
In-Vitro Pyrogen Detection, the New TrendSubcategory: Industrial Microbiology Misc.Duration: 60 minutes Presented: 25 October, 2018 The new PyroMAT™ System provides pharma companies with a robust solution to make the move to in vitro Pyrogen Test with a ready-to use kit. Abstract: For pharmaceutical companies, patient safety has always been the priority. That's why pyrogen detection has become a mandatory Quality Control test for release of any parenteral drug. With the Monocyte Activation Test, the only in vitro test for the detection of the full range of pyrogens (including endotoxin and Non Endotoxin Pyrogens), it's now time to move away from animal-based test for pyrogen detection. The new PyroMAT™ System provides pharma companies with a robust solution to make the move to in vitro Pyrogen Test with a ready-to use kit! What You Will Learn:
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Revised ISO 11133 and ISO16649 Food Microbiology Standards: How this Affects Your LabSubcategory: Industrial Microbiology Misc.Duration: 60 minutes This webinar explains the amendments of the ISO 11133:2014 and the revised ISO 16649 part 1:2018 for enumeration of Escherichia coli in the food chain. Abstract: ISO 11133:2014 is a mandatory standard for all ISO 17025-accredited labs for microbiological analysis of food, feed and water. It describes the preparation, production and performance testing of culture media from this whole area. Recently published amendment 1:2018 contains corrections and additional explanations whilst future amendment 2 will describe the performance testing of confirmation media and reagents. ISO 16649-1, which specifies a horizontal method for the enumeration of β-glucuronidase-positive Escherichia coli, has also been revised. The method uses a colony-count technique after resuscitation using membranes and incubation at 44 °C on TBX agar. There are three horizontal methods (ISO 16649-1, ISO 16649-2 and ISO 16649-3) for the enumeration of β-glucuronidase-positive Escherichia coli, all parts are for general application. Parts 1 and 3 include a resuscitation step and should be used in preference for foodstuffs likely to contain sub-lethally injured cells. This webinar explains the latest changes in ISO 11133 and ISO 16649 and will give an outlook on the future of both standards. Speakers: |
Convenient Media: A Reliable Alternative to Traditional Methods?Subcategory: Industrial Microbiology Misc.Duration: 60 minutes Presented: 27 September, 2018 In this webinar, we will discuss how these alternative methods can change your workflow, we will analyze their performance, with a particular focus on difficult matrices. Abstract: Your microbial testing workflow is reliant upon your choice of culture media, not only in terms of storage and handling, but more importantly, can you trust the results? Many new culture media products have recently entered the market, so choosing the right one can be tricky. Are convenient culture media products a reliable alternative to traditional methods? In this webinar, we will discuss how these alternative methods can change your workflow, we will analyze their performance, with a particular focus on difficult matrices. Speakers: |
Industry Trends in Aseptic SimulationSubcategory: Industrial Microbiology Misc.The media fill test is one critical component of the aseptic process simulation. This webinar will:
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Essential Components for Implementation of a Robust Environmental Monitoring ProgramSubcategory: Industrial Microbiology Misc.This webinar pieces together the essential components and best practices for successful implementation of an environmental monitoring program. Key learning points for this webinar:
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What's Bugging you about Bioburden and Sterility TestingSubcategory: Industrial Microbiology Misc.In this webinar you will learn how a deeper understanding of membrane filtration can help with method development for bioburden and sterility testing. Key learning points for this webinar:
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The Whole Blood Assay: Detection of Broad Spectrum of Pyrogens and Examples of Medical Device TestingSubcategory: Industrial Microbiology Misc.In this webinar you will learn how Pyrogens in pharmaceuticals, medical devices, biotherapeutics and cosmetics can cause fevers in humans and are potentially life-threatening. Yet standard pyrogen detection methods have drawbacks. The Limulus Amoebocyte Lysate (LAL) test only identifies endotoxins, while the rabbit pyrogen test (RPT) endangers animals. Fortunately, the MAT (Monocyte-Activation Tests) alternative covers a much broader range of pyrogens and is completely animal-free. In our insightful webinar you will get a closer look at the whole blood assay, non-endotoxin pyrogens detection, and pyrogen testing in medical devices. Speaker: |
Media Fill Tests: Vegetable Peptone Alternatives and FilterabilitySubcategory: Industrial Microbiology Misc.A comprehensive comparison study provided by culture media manufacturers can help to reduce the effort for internal validation. An example of such a study will be discussed. Abstract: Soybean Casein Digest Medium (SCDM) or Tryptic Soy Broth (TSB) is the only medium for aerobic media fill which is mentioned with formulation in international Pharmacopeias. Yet, the risk of contaminations with Transmissible Spongiform Encephalopathies and the documentation effort involved have caused the use of media with alternative, vegetable peptones to become more and more popular in recent years. These Vegetable Peptone Broths require a validation to prove equivalence with standard TSB. One of the most frequent issues related to the use of dehydrated culture media for aseptic filling process simulations is filterability, especially challenging with Vegetable Peptone Broth. A recently conducted comparison study of the most relevant dehydrated media fill broths commercially available reveals considerable differences between both the media and the filter types commonly used for this application. Speaker: |
Cleanroom and Isolator Instrumentation: Best PracticesSubcategory: Industrial Microbiology Misc.A comprehensive comparison study provided by culture media manufacturers can help to reduce the effort for internal validation. An example of such a study will be discussed. Abstract: Choosing and implementing your environmental monitoring instruments is critical for a safe production and continued compliance. Ensure optimum performance from your microbial environmental monitoring in aseptic manufacturing processes in cleanrooms and isolators. Merck can support the quick implementation of specifically designed and validated products along with the reliable tests to be fully compliant with current regulations. We provide a high level of expertise and good practices on both applications and equipment used within quality control laboratories. We have gained the regulatory and technological know-how to offer you a comprehensive range of best-in-class equipment and professional services. Speaker: |
Revised ISO Food Microbiology Standards for Detection of Listeria, Enterobacteriaceae and CronobacterSubcategory: Industrial Microbiology Misc.How can you stay ISO certified in the current environment of an ever-increasing, but necessary regulation? Abstract: The ISO food microbiology standards are changing for ISO 11290, ISO 21528, and ISO 22964. All food products and ingredients intended for human consumption and the feeding of animals are implicated, along with environmental samples in food production and handling areas. Our food microbiology expert, member of the German ISO delegation, will guide you through the most recent changes for handling the testing of Listeria (ISO 11290), Enterobacteriaceae (ISO 21528), and Cronobacter (ISO 22964) to help you remain compliant. Speakers: |
Pharma/Biopharma Manufacturing
Browse subcategory:
Subcategory: Biopharm Services and Solutions |
Demonstrating Technical Excellence in Contract ManufacturingSubcategory: Biopharm Services and SolutionsDuration: 1 hour Date: 24 October, 2024 In these Tech Talks you will gain insights from industry experts on:
Join our exclusive Tech Talks featuring a series of cutting-edge presentations on demonstrating technical excellence in process development and manufacturing for antibody-drug conjugates (ADCs) and bioconjugates. As an established CDMO, we will provide valuable insights on successfully scaling up from PAD to manufacturing, leveraging an integrated linker-payload supply chain, and implementing Process Analytical Technology (PAT). These innovative approaches and technologies are essential for ADC developers to bring novel therapies to patients. Register now to gain access to expert knowledge that will drive innovation and accelerate your ADC development and manufacturing program. Speakers: |
Securing Your Cell Banks: Embracing Closed System Technologies for EU GMP Annex 1 ComplianceSubcategory: Biopharm Services and SolutionsDuration: 1 hour Date: 29 August, 2024 In this webinar, you will learn:
Annex 1 of the European Union's (EU) Good Manufacturing Practice (GMP) guidelines emphasizes the importance of closed system processing in pharmaceutical manufacturing, by accomplishing material transfer via aseptic connections of auxiliary materials and equipment. The guidelines also address the design, construction, integrity, sterility, validation, monitoring, and control of closed systems to ensure aseptic conditions and minimize the risk of contamination. Join us to explore how our cell bank manufacturing service is striving to establish a closed manufacturing process, detailing the development of our two-phase approach which promises the most reliable process to date to meet Annex 1 expectations. Speaker: |
The Road to Approval: Viral Clearance Strategies for Non-Enveloped Viral VectorsSubcategory: Biopharm Services and SolutionsDuration: 1 hour Date: 20 June, 2024 In this webinar, you will learn:
The updated ICH Q5A(R2) guideline incorporates viral vectors in its viral safety guidance, including the expectation for a viral clearance study for non-enveloped viral vectors. Designing a viral clearance study for a non-enveloped viral vector requires thoughtful consideration of the risk of any adventitious, endogenous or production viruses that might be present as a potential contaminant. Viral clearance steps should be implemented in the manufacturing process that will selectively inactivate or remove potential contaminants without any detrimental impact to the vector. A well-designed viral clearance study will contribute to the assurance of a vector’s overall viral safety on your journey to regulatory approval. Speaker: |
Make More Lentivirus and Make it Right the First TimeSubcategory: Biopharm Services and SolutionsDuration: 39 minutes Date: 6 June, 2024 In this webinar, you will discover how our comprehensive lentivirus platform enables clinical and commercial success by:
Embrace higher titers and robust yield. Our optimized, end-to-end VirusExpress® lentivirus platform delivering maximized production and quality outcomes to enable the success for your cell or gene therapy. Benefit from accelerated development timelines, de-risked manufacturing, and achieve the performance and product quality critical for clinical trials, all while delivering a lower cost per therapeutic dose. Speaker: |
To Target or Not to Target: NGS Applications for Biosafety TestingSubcategory: Biopharm Services and SolutionsDuration: 1 hour Date: 23 April, 2024 In this webinar, you will learn about:
There is an evolution of new molecular technologies and a responsibility to incorporate alternate technologies for the detection of adventitious agents. NGS has emerged as a key method that may be used to detect virus contamination throughout the development of biologics products. In the recent revision of the ICH Q5A guidance the replacement of in vivo, in vitro and species-specific applications with NGS has been discussed and the terms, targeted and non-targeted NGS, were introduced. Within this webinar, the definition of NGS applications, their applications and specific case studies will be presented to support use of this core technology as part of risk assessment of biologics products. Speakers: |
Solving Synthesis Challenges: Small Molecule CTDMO StrategiesSubcategory: Biopharm Services and SolutionsDuration: 1 hour, 45 minutes Date: 22 February, 2024 In this technical symposium, industry experts will present about:
Embark on your small molecule drug development journey with advice from industry experts. Navigate the intricacies of developing, synthesizing, and sourcing across a wide range of segments such as HPAPIs, APIs, Next-Generation Conjugates, Linker-Payloads, PEGs, and Targeted Protein Degradation. In this symposium, learn tech transfer approaches to ensure your first GMP batch is right first time, master how to deploy phase appropriate quality for efficiencies in your drug development process, explore a case study in overcoming obstacles along the journey to commercialization, and examine how our small molecule offer can accelerate your ADC therapies. Unlock the secrets to seamless small molecule contract development and manufacturing with Millipore® CTDMO Services. Two Speakers: |
mRNA - Powering Life Changing TherapiesSubcategory: Biopharm Services and SolutionsDuration: 1 hour, 27 Minutes Date: 12 October, 2023 In this technical symposium, industry experts will be presenting about:
The mRNA landscape is rapidly evolving, unfolding opportunities to bring life changing therapies to patients and overcome process and analytical challenges on the journey of mRNA-based drugs to market. Join industry experts to learn about strategies to accelerate mRNA therapies and enable scalability and process efficiency from preclinical to commercial. Get an overview of our integrated CTDMO offering, our newly launched mRNA Center of Excellence for robust mRNA manufacturing and our services for analytical development and product characterization. Two Speakers: |
Scaling for Commercialization: Considerations for Large-Scale API ProductionSubcategory: Biopharm Services and SolutionsDuration: 1 hour Date: 14 September, 2023 In this webinar, you will learn:
As programs progress through the clinic and require scaling to larger batch sizes, a seasoned commercial partner is critical for program success. Key considerations such as risk mitigation, production scalability, regulatory filing support, and specialized technological capabilities should be thoroughly evaluated. In this webinar, we take a look inside our latest capacity expansion for large-scale GMP API production located in Darmstadt, Germany. With a commitment to phase appropriate quality, flexibility, and sustainability the right CTDMO partner can help navigate the complexities of large scale programs. Speakers: |
What's Really in the Box? Characterizing AAV Encapsidated Nucleic Acid Sequences Using NGSSubcategory: Biopharm Services and SolutionsDuration: 30 minutes Date: 22 June, 2023 In this webinar, we will explore:
Due to the nature of AAV particle production, non-targeted sequences may be packaged along with the gene of interest. Even in an optimized system, these non-target nucleic acids can comprise between 1-2% or greater of the entire nucleic acid payload. Characterizing the non-targeted sequences that may be packaged in the vector is important for establishing the safety profile of the final product. NGS can provide a clearer picture of all encapsidated sequences within the AAV particles. In this webinar, we discuss characterization of several representative AAV molecules using NGS, including the sequencing process, bioinformatic analysis, and representative results. Speakers: |
Building Better Degraders: Targeted Protein Degradation Partners from Lead Discovery to ProductionSubcategory: Biopharm Services and SolutionsDuration: 1 hour Date: 15 June, 2023 In this webinar, you will learn about:
Targeted Protein Degradation (TPD) has created a paradigm shift and emerged as a front runner in drugging many "undruggable" targets. As a new modality, it poses unique challenges for lead discovery as well as API development and manufacturing. We will focus on the latest advances in chemical building blocks for protein degradation, including warheads, linkers, and ligands, and how they can be used to build better degraders. Once a candidate has been identified, selection of the right CDMO can take a phase appropriate approach to develop with commercial readiness in mind, provide partnered quality & regulatory support, and offer batch scalability as you progress through the clinic. Speakers: |
Transforming the Biopharma Supply Chain, eData Solutions for Agility and Manufacturing EfficiencySubcategory: Biopharm Services and SolutionsDuration: 1 hour Date: 1 June, 2023 In this webinar, you will learn:
Transforming the BioPharma supply chain to future ready requires digital technologies. A digital supply chain and access to real-time data enables process improvements and proactive logistical responses to mitigate supply disruptions. This webinar will discuss how eData enables process automation and simplification, including critical analytics and logistics data from suppliers of raw materials and production consumables. How integration of logistical eData is key to developing predictive analytics and to improve resilience. Also discussed is next steps to a industry-wide eData solution and how manufacturers can adopt a standardized digital platform. Speakers: |
Who Counts as an Expert? Establishing Analytical Methods for Emerging mRNA-based TherapiesSubcategory: Biopharm Services and SolutionsDuration: 45 minutes Date: 25 May, 2023 In this webinar, we will explore::
The success of the first vaccines for SARS-CoV-2 demonstrated both the effectiveness of mRNA technology and the speed at which new vaccines could be developed using such a platform. The sudden emergence of this novel modality has necessitated the rapid development of analytical methodologies to ensure product quality and meet the evolving regulatory requirements. This challenge is further complicated by the different nature of mRNA drug substance and the formulated drug product, often in the form of a lipid nanoparticle (LNP). In this webinar, we describe the use of cutting-edge technologies to assess critical quality attributes of both mRNA drug substance and drug product. Speakers: |
Key Benefits of PCR-based mRNA Manufacturing for Clinical DevelopmentSubcategory: Biopharm Services and SolutionsDuration: 39 minutes Date: 16 May, 2023 In this webinar, you will learn:
To unlock the potential of your mRNA therapies and accelerate your mRNA development and manufacturing program, discover the benefits of our novel PCR-based mRNA drug substance manufacturing process. With this innovative and flexible process, we can provide mRNA at all scales and qualities for all stages of a mRNA program life cycle, from pre-clinical to commercial. Learn about our truly integrated mRNA-LNP CDMO offering, and how we can support you as the single-source partner along all critical steps from mRNA drug substance manufacturing, through lipids and lipid nanoparticle (LNPs) to fill & finish of the final drug product. Speakers: |
Streamlining Viral Vector Development and Manufacturing for Gene TherapiesSubcategory: Biopharm Services and SolutionsDuration: 42 minutes Date: 11 May, 2023 In this webinar, you will:
As clinical success, innovation and investment in cell and gene therapy grows, emerging therapies are targeting more chronic conditions and cancers, in addition to rare diseases. This makes viral vector manufacturing—a critical component in gene and cell therapy— in demand. As more biopharma innovators focus on developing new therapies, many are choosing to partner with a CDMO that can support them from preclinical through commercialization. Join our viral vector experts to learn more about our capabilities and solutions for gene therapy production as they highlight key features of our technologies and infrastructure through a virtual tour of the GMP manufacturing facility. Speakers: |
Advancements in Process and Payload Development for ADCs and Next-Generation BioconjugatesSubcategory: Biopharm Services and SolutionsDuration: 1 hour, 38 minutes Date: 27 April, 2023 In these Tech Talks you will learn from our experts about:
We invite you to a series of presentations on process and payload innovation for ADCs and bioconjugates. As an established CDMO, we will share insight on adapting conjugation processes and analytics to non-traditional ADCs and highlight the integration of PAT into development and manufacturing. Also bringing focus to linker-payloads, we will discuss accelerated strategies to access and solubilize drug linkers. Together, these templates and technologies will continue to help ADC developers confidently bring novel therapies to patients. Speakers: |
Maximizing the Value of your AAV Using Small Volume AAV TestingSubcategory: Biopharm Services and SolutionsDuration: 30 minutes Date: 25 April, 2023 In this webinar, you will learn:
Analyzing recombinant Adeno-Associated Virus (rAAV) can be challenging as significant portions of process development and clinical trial material batches are consumed during the measurement of critical quality attributes (CQAs). However, measuring specific rAAV CQAs such as identity and purity is an essential part of gaining process understanding, developing control strategies, and mitigating the risks associated with an AAV drug program. Join this webinar to learn our approach to method development where we can measure more than one AAV CQA within a single analytical run. This small volume AAV testing package reduces the amount of test material required so you can treat more patients. Speaker: |
Client Case Study: How an Optimized Purification Platform Can Speed mAbs Clinical ProductionSubcategory: Biopharm Services and SolutionsDuration: 1 hour Date: 23 March, 2023 In this webinar, you will learn how a process platform can help:
Getting your antibody to clinical trials faster while being able to build a robust, scalable, and high-yielding process is a challenge many biotech companies face. By outsourcing to a CTDMO, you can benefit from an optimized platform process. In this webinar, we will showcase our purification development platform, including an MMC* step and how it allowed our client Igyxos Biotherapeutics to simplify and accelerate their clinical trial supply while achieving high-quality material. *mixed-mode chromatography Speakers: |
Custom LNP Formulation Development - The new Early Formulation Screening Service as a Key Partner for SuccessSubcategory: Biopharm Services and SolutionsDuration: 1 hour Date: 15 December, 2022 In this webinar, you will learn:
Nucleic acids are known to be fragile payloads. To enable their safe and efficient delivery into cells, the RNA payload needs to be “packed” into a delivery vehicle, the lipid nanoparticles (LNP). This webinar gives insight into our capabilities for customized LNP formulation development for novel therapeutic modalities. The manufacturing, optimization, analytical characterization, in vivo testing, and scale-up strategy for LNP will be discussed. With our newly launched service, we aim at simplifying the road to market, by providing preclinical development service, delivering animal trial material (including for GLP tox studies) and supporting in-house transfer to clinical GMP manufacturing. Speakers: |
From Discovery to Market Readiness, CTDMO Services as an EnablerSubcategory: Biopharm Services and SolutionsDuration: 30 minutes Date: 13 December, 2022 In this webinar, you will learn:
In the earliest phases of biologics development, biotech companies are challenged to move fast while generating data on their lead molecule and its manufacturability. How do you make sure that your process data don’t get lost in translation between clinical and commercial manufacturing? In this webinar, we will present how our mAbs CTDMO* Services can be an enabler for innovators to successfully bring their molecule to market with the advantages of in-house testing, harmonized single-use equipment and integrated raw material supply. *Contract Testing, Development, and Manufacturing Organization Speakers: |
Characterization of Monoclonal Antibodies and Antibody Drug Conjugates by Surface Plasmon ResonanceSubcategory: Biopharm Services and SolutionsDuration: 1 hour Date: 8 December, 2022 Highlights of this webinar:
Characterization of therapeutic monoclonal antibodies (mAbs) or Antibody drug conjugates (ADCs) is challenging due to their ability to bind to a variety of proteins via their Fc and Fab domains, giving rise to diverse biological functions associated with each domain. The Fc domain of mAbs interacts with Fc receptors with varying affinities, which can influence biological processes such as Complement-dependent cytotoxicity (CDC) and Antibody-dependent cellular cytotoxicity (ADCC), transcytosis, phagocytosis, and/or serum half-life. An important characteristic of an antibody is its Fc effector function. Antibodies can be engineered to obtain desired binding of the Fc region to Fc receptors expressed on effector cells. Hence, it is crucial to evaluate the binding interaction of mAbs/ADC with Fc receptors in the early phase of drug development to understand the potential biological activity of the product in vivo. Surface Plasmon Resonance (SPR) is a powerful technique to establish binding kinetics in real-time, label free, and high sensitivity with low sample consumption. Along with target antigen binding, it is crucial to evaluate the binding interaction of antibodies and ADCs with Fc receptors. Our SPR case studies investigated the impact on binding kinetics of ADCs with different linkers and the binding interactions of SARS-CoV-2 spike protein variants and evaluated the neutralizing ability of therapeutic mAbs. SPR characterisation can be facilitated in all stages of the product life cycle to ensure the quality and safety of mAbs and ADCs. Speakers: |
Going Viral: Process and Facility Design Considerations for CGT ManufacturingSubcategory: Biopharm Services and SolutionsDuration: 1 hour Date: 8 November, 2022 In this webinar, you will learn:
Viral Vector therapies are gaining increasing traction with more and more companies looking to take the leap from other Biologics. In the early stages of clinical development, it’s expedient to outsource to de-risk the venture. For CGTs, this can be challenging because CDMO capacity is limited and the manufacturing complexity is higher than for other biologics. Nevertheless, experience in bioprocessing can be leveraged. Understanding the similarities and differences between CGT and other biologics processes is crucial to design a facility. Comparisons will be made between mAb and viral vector facility layouts. Based on this, considerations for your strategy development will be explored. Speakers: |
A Rapid, Innovative Approach to Release Testing with Blazar® CHO AOF Virus PanelSubcategory: Biopharm Services and SolutionsDuration: 45 minutes Date: 13 October, 2022 In this webinar, we will introduce the Blazar® CHO AOF assay and discuss:
Innovative molecular methods will allow mAbs manufacturers to deliver critical therapeutic agents to patients faster. The Blazar® CHO AOF virus panel is a powerful tool to accelerate bulk harvest testing with the potential to replace slower culture-based in vitro virus detection methods. It is a degenerate PCR-based assay for broad detection of adventitious agents in materials grown with animal origin free (AOF) media and reagents. A degenerate primer approach allows for broader coverage than traditional PCR. Blazar® degenerate primers are designed to target specific viral risks while detecting related viral variants and newly emerging viruses. Speakers: |
Key quality Attributes for mRNA Drug Substance Performance - Considerations and Best PracticesSubcategory: Biopharm Services and SolutionsDuration: 53 minutes Date: 1 September, 2022 In this webinar, we will learn:
mRNA-therapeutics have become the most discussed and growing modality in recent years. While COVID vaccine development occurred in record time, critical design and quality attributes must be considered when developing mRNA for other therapeutic applications. This presentation covers the key quality attributes and analytics impacting mRNA performance, including best practices to ensure success. Furthermore, we discuss how our unique PCR-based mRNA CDMO Service technology can accelerate mRNA development and manufacturing for our customers. Speakers: |
Moving your Gene Therapy from R&D to IND: How to navigate the Regulatory LandscapeSubcategory: Biopharm Services and SolutionsDuration: 53 minutes Date: 28 July, 2022 In this webinar, we will answer:
Novel therapies, including cell and gene therapies, continue to be central to innovation in healthcare and represent the fastest growing area of therapeutic medicine. As a consequence, the number of gene therapies undergoing clinical trials has increased significantly in the last five years. Manufacturing processes for these novel therapeutics are very complex with a high risk of contamination. Regulatory agencies world-wide have responded by issuing guidance to outline their expectations for development and manufacture of cell and gene therapies. Currently, regulatory guidance is not harmonized globally and can often lead to confusion within industry and increased risk of non-compliance. Speakers: |
Identity testing by NGS as a means of risk mitigation for viral gene therapiesSubcategory: Biopharm Services and SolutionsDuration: 45 minutes Date: 19 July, 2022 In this webinar, we will explore:
Imagine you’ve just completed a manufacturing run for your viral vector. Identity testing is performed to confirm the vector sequence. But when the results come back the data reveals unexpected sequence variants! With an appropriate risk mitigation testing strategy, this situation can be prevented. The situation described above is not hypothetical, and happens more that you think, costing valuable time and resources. Investigatory testing has shown that sequence variants present in starting materials (e.g. plasmids) are likely to make their way to the final product. Adequate identification of low-level variants with an appropriately sensitive method is critical in ensuring the quality of the final product. A risk-based testing strategy, in the context of identity, for viral vector manufacturing will be presented, focusing on key testing points. NGS assays for identity and variant detection will be highlighted due to their extremely sensitive nature compared to traditional approaches. Speakers: |
Balancing Risk, Speed and Cost in Biopharmaceutical Process Development & ManufacturingSubcategory: Biopharm Services and SolutionsDuration: 1 hour Date: 16 June, 2022 In this webinar, you will learn:
Biotech organizations can encounter a variety of challenges, both expected and unexpected, during biopharmaceutical development. Anticipating and mitigating these challenges will ensure that the process development and manufacturing timelines and deliverables will be maintained. In this webinar industry experts will provide insights on how biotech organizations and their CDMO partners can effectively plan and execute a successful drug development program, from pre-clinical to IND. Two case studies will be presented that illustrate how analytical and process development activities are performed to meet timelines and process needs. Speakers: |
Rapid Replication Competent Adenovirus (rRCA) Detection: Accelerate your Lot ReleaseSubcategory: Biopharm Services and SolutionsDuration: 45 minutes Date: 28 April, 2022 In this webinar, you will learn about:
Testing for presence of replication competent adenovirus (RCA) is a key component to ensure patient safety and a requirement for all biologicals manufactured using adenoviral vectors. For many adenoviral-based products, the RCA assay is a rate-limiting assay for lot release. Join this webinar to learn about a rapid RCA detection assay currently in development, which combines a 7-day culture assay with a highly sensitive molecular endpoint specific for RCA. The method can detect presence of as little as 1 RCA in adenoviral vector material at an approximate concentration of 5x107 - 2x108 vector particles (VP)/mL, making it a suitable method to meet regulatory requirements while accelerating your lot release timelines. Speakers: |
Top Reasons to Outsource your Early Biologic Development and Manufacturing to a CDMOSubcategory: Biopharm Services and SolutionsDuration: 45 minutes Date: 10 February, 2022 In this webinar, you will learn about:
A recent survey commissioned by our company across more than 50 small, mid-sized and large biopharmaceutical companies worldwide, shed light on the key reasons why biotechs outsource their early biologic development and manufacturing to a CDMO. In this 20-minute panel discussion, members of our End-to-End Solutions team, part of the BioReliance® portfolio, will offer their perspectives on what we heard from respondents. We will discuss major hurdles biotechs mentioned and how a customer-centric CDMO partnership can help overcome these, dismissing the idea of one-size-fits-all. Speakers: |
ChetoSensar™ Technology Platform: Consider it DisSolvedSubcategory: Biopharm Services and SolutionsDuration: 30 minutes Date: 16 November, 2021 Detailed description: The optimization of solubility is an integral cornerstone in ADC development. En route towards novel ADCs, the optimization of solubility of drug candidates is still a challenge to tackle as the linker payloads alter the characteristics of the biologic. Poor solubility impacts not only manufacturability but as well DMPK properties and therefore the therapeutic window. The novel ChetoSensar™ technology platform, a chemical modifiable carbohydrate motif, addresses this topic. The attachment of ChetoSensar™- tagged linkers to biomolecules increases the hydrophilicity and therefore decreases aggregation. The ChetoSensar™ oligosaccharide can be used flexibly and works with a variety of linker and payload combinations. The obtained ADCs showed a favorable efficacy in vivo and thus expanded our reach to challenging ADC constructs. In this lecture, we introduce this technology and highlight its use within the ADC field. Speakers: |
Advantages of Developing Processes and Manufacturing API with Single-Use TechnologiesSubcategory: Biopharm Services and SolutionsDuration: 1 hour Date: 28 October, 2021 In this webinar, you will learn about:
When biopharma companies move towards commercial manufacturing their focus shifts towards demand forecast, capacity constraints, and lifecycle management. Whether you chose a CDMO partner as a second-source manufacturer or to fully outsource your commercial manufacturing, quality, flexibility and cost-effectiveness are top priorities. In this webinar, our experts will shed light on how we are currently designing our new biologic GMP commercial manufacturing facility in France that will go live in one year from now. Flexibility is at the heart of our facility planning and set-up. We will showcase the advantages of single-use technology and its impact on the plant’s running costs, flexibility and capabilities e.g. for perfusion. In 2012, we converted our GMP clinical manufacturing facility into 100% single-use technology. Today, our process development capabilities and our GMP clinical drug substance supply are based on single-use technology. Being a CDMO and a product provider, we are leveraging our industry leading single-use technologies to help our customers minimize risk and optimize speed for scale up and tech transfer. Using and sharing our first-hand experience combined with modern facility conceptual design, we will walk you through our facility planning, the ballroom concept and showcase what we mean by flexibility. Speakers: |
Releasing Your AAV Therapy with Confidence: Regulatory Considerations and Key AssaysSubcategory: Biopharm Services and SolutionsDuration: 1 hour Date: 29 July, 2021 In this webinar, you will learn:
Adeno-associated virus (AAV) vectors possess a number of advantages for use in human therapy including: high titer preparations, low immunogenicity, capacity to infect a wide range of cell types, and replication deficiency. Even with these advantages, there are biosafety concerns to consider when using AAV vectors. This webinar will discuss key regulatory considerations across the manufacturing process, from the helper/packaging plasmids through to lot release testing. We will highlight critical assays that are required and delve into specifics on replication competent AAV testing and infectious titer determination by TCID50. Speakers: |
Getting it Right. A Candid Conversation About Remote Viral Clearance StudiesSubcategory: Biopharm Services and SolutionsDuration: 1 hour Date: 1 July, 2021 In this webinar, you will:
Join us as our head of project management discusses preparing for a viral clearance study from the client perspective with a technical specialist. Discover how we partner with you early on study design and discuss study preparation considerations, potential challenges, and how we deliver best-in-class Provise™ clearance services without the need to ever travel. Speakers: |
Optimize Your Process Validation PackageSubcategory: Biopharm Services and SolutionsDuration: 1 hour Date: 24 June, 2021 In this webinar, you will discover more about:
As you advance your biologic drug towards commercial manufacturing and Marketing Authorisation Application (MAA), you need to start process validation activities, and in many cases, you have limited information and data available from the clinical stage. Quality By Design (QBD) has become the gold standard to ensure quality risk management throughout the product life cycle. Statistical Design of Experiment is the method of choice to achieve this goal but finding the right balance between a large number of experiments and speed without sacrificing quality is not always easy. Actually, there are opportunities for more flexible approaches that focus on the critical process parameters and an appropriate process validation strategy. In this webinar, we will focus on an adaptive, risk-based approach for an optimized process validation package that help biopharma companies accelerate their time to market. The main objective is to demonstrate that the manufacturing process is capable of consistently producing acceptable quality products within the commercial manufacturing conditions. Outsourcing to an experienced CDMO with deep process understanding and robust quality systems in place can give you more options for flexibility and speed, while maintaining quality and patient safety. Our validation experts will walk you through the steps of a risk-based approach, the residual risk and how we have optimized the validation strategy for clients. Speakers: |
Smart Bioprocess Data Management for Statistical Process Control and Advanced AnalyticsSubcategory: Biopharm Services and SolutionsDuration: 1 hour Date: 15 June, 2021 In this webinar, you will learn:
End-to-end knowledge management is required during the life cycle of biopharmaceutical processes from development to manufacturing (QbD, PAT, CPV). In Bioprocessing 4.0, the wide range of data is important for scientific understanding, and speeding up data acquisition to analysis and control is essential, the real-time monitoring and smart data management are expected to push boundaries and unlocking unprecedented possibilities to transform drug manufacturing. In this presentation, we would highlight the current challenges of bioprocessing data utilization and introduce the solution, and demonstrates the benefits of Bio4C™ ProcessPad and real-time monitoring of ProCellics™ Raman analyzer. Speakers: |
Unveiling the Potential of your AAV Gene Therapy: Orthogonal methods to understand and define CQAsSubcategory: Biopharm Services and SolutionsDuration: 1 hour Date: 8 June, 2021 In this webinar, you will learn:
The potential of gene therapies to cure previously untreatable diseases has spurred the development of novel drugs, including those based on Adeno-Associated Virus (AAV). As with all biopharmaceuticals, it is important to identify and monitor the critical quality attributes (CQAs) of these products to ensure their safety and efficacy. In this webinar, we will present a range of orthogonal methods to understand and define the CQAs of AAV products. These include assays for the confirmation of capsid protein identity and quantity, as well as the characterization of important product-related impurities, such as aggregates. Together these methods represent a comprehensive analytical testing package to support the characterization and lot release of AAV products. Speakers: |
Setting up for Successful Lot Release TestingSubcategory: Biopharm Services and SolutionsDuration: 1 hour Date: 18 May, 2021 In this webinar, you will learn:
CHO cells continue to serve as a key cell substrate for the manufacturing of recombinant proteins that span beyond therapeutic monoclonal antibodies and including subunit vaccines. In this presentation, we will cover the CMC testing requirements with CHO production platform for global commercialization, Lot release testing of product intermediates and final product, product-specific qualification study and highlight the application of new testing methods and the benefits they bring to advance Lot Release Testing. Speakers: |
Subcategory: Cell Culture |
Developing Robust Media Formulations for Optimal Productivity and Product QualitySubcategory: Cell CultureDuration: 1 hour Date: 1 October, 2024 In this webinar, you will learn:
Maximizing productivity and quality in your upstream biologic manufacturing. Join us for an exclusive webinar on developing robust cell culture media formulations. Explore the critical role of leveraging diverse libraries and raw material characterization and gain valuable insights into data-driven development for optimal productivity and quality. From statistical design approaches to advanced explorations, this webinar will equip you with the knowledge to enhance your cell culture media development strategies. Don't miss this opportunity to stay at the forefront of bioprocessing innovation! Speakers: |
How to Boost AAV Titer with Feed Supplementation in both HEK293 and Sf-9 PlatformsSubcategory: Cell CultureDuration: 1 hour Date: 18 June, 2024 In this webinar, you will learn:
To respond rapidly to urgent customers inquiries for recommendations to increase AAV titers in established AAV production processes, we evaluated a selection of our company's media and feed products as supplements during AAV production. We found Cellvento® ModiFeed Prime significantly increased AAV titers in HEK293 cell lines when supplemented post-transfection and in Sf-9 cell lines when supplemented post-infection. The volume and timing of the supplementation are critical for maximizing AAV titers and will be reviewed during this webinar. Speaker: |
AAV Upstream Process Development: A collaboration with Synplogen JapanSubcategory: Cell CultureDuration: 1 hour Date: 6 June, 2023 In this webinar, you will hear from the Synplogen team about their:
Gene therapies have revolutionized the way we can treat diseases of previously unmet need. However patient urgency and high costs mean that more efficient methods of production are sorely needed. AAV vectors are forecasted to be the dominant form of gene therapies because they have superior safety profiles. Therefore, solutions for rapid and scalable production will be key to bring these therapies to patients. Our partner Synplogen will share their experience in developing a robust and scalable upstream AAV platform for gene therapies. Speakers: |
CellPrime® rLR3 IGF-1 Optimizing Cell Culture ProductivitySubcategory: Cell CultureDuration: 38 minutes Date: 16 March, 2023 In this webinar, you will learn:
CellPrime® rLR3 IGF is used to optimize cell culture formulations to increase cell proliferation, productivity, and viability. With an exact match for the Type I IGF receptor and a lower affinity for IGF binding proteins, CellPrime® rLR3 IGF has increased effectiveness in serum-free cell culture media. We will focus on how CellPrime® rLR3 behaves in cell culture media and provide details on how supplementing media with Cellprime® rLR3 IGF-I alone, or in combination with insulin, can speed growth as well as increase viable cell density and protein production. Speaker: |
Flexible, Simplified, and Scalable Solutions for AAV Viral Vector ProductionSubcategory: Cell CultureDuration: 1 hour Date: 22 October, 2022 In this webinar, you will learn:
The adeno-associated virus (AAV) is the leading viral vector for in vivoin vivo gene therapy. Currently, production is labor intensive and expensive because of adherent cell culture processes. The use of stirred-tank bioreactors allows scalable and robust processes to be developed to meet the most demanding needs for high-dose indications that target large organs, e.g. muscle, skin or blood. High-performing cell culture media is also crucial to ensure consistent supply. Here, we highlight the development of two suspension-based AAV upstream production platforms, and describe simplified cell culture processes to enable efficient and cost-effective solution for large scale AAV production. Speaker: |
Cold hard facts: Implementing high cell density cryopreservation in your intensified seed trainSubcategory: Cell CultureDuration: 1 hour Date: 15 September, 2022 In this webinar, you will:
This presentation explores the use of a high cell density cryopreservation (HCDC) method that utilizes bag assemblies specifically designed for freezing cells at higher densities and larger volumes, enabling to directly inoculate the N-2 bioreactor. The integration of a perfused N-1 step in upstream process is highlighted to either decrease facility footprint or to be able to inoculate final fed-batch N-stage with a higher cell density as a conventional fed-batch. This streamlined method of initiating cell expansion can reduce the number of intermediate cell culture unit operations, allowing to shorten expansion process by 10 days and to decrease the runtime of final N-stage bioreactor. Speaker: |
Get the Most out of Your Fed-batch Process with Cellvento® ModiFeed Prime COMPSubcategory: Cell CultureDuration: 39 minutes Date: 27 September, 2022 In this webinar, you will learn:
Introducing Cellvento® ModiFeed Prime COMP, a new easy to hydrate, single-part pH neutral feed. This highly concentrated, compacted feed reduces the volume to be added to bioreactor while increasing product yield. The feed is also stable at room temperature when protected from light, allowing it to remain connected to the bioreactor for easy multiple feedings, thereby streamlining workflows and reducing contamination risk. The feed supports optimal cell growth and high productivity for wide range of industrial suspension CHO cell lines. When used in combination with Cellvento® and EX-CELL® Advanced media, it boosts productivity beyond our existing feeds and competitive feeds tested. Speaker: |
Quality Improvement in Implemented Cell Line Development Process Based on the CHOZN-GS SystemSubcategory: Cell CultureDuration: 1 hour Date: 31 May, 2022 In this webinar, you will learn:
Upstream process development is a critical step in ensuring that the needed protein quality is met on a large-scale. However, due to the inherent properties of the selected clone, the Research Production Cell Banks, which is derived mainly based on initial high productivity, frequently delays the subsequent process development. In the cell line development stage, we recently used the CHOZN-GS system to apply our quality-driven Fc-fusion protein screening procedures to select appropriate clones that ranged in the target product quality. Our strategies can also be used as an enhanced cell line development platform with high titer and developability. Speaker: |
Addressing Downstream Challenges with Complex InjectablesSubcategory: Cell CultureDuration: 1 hour Date: 29 March, 2022 In this webinar, you will learn:
The complex injectable market is gaining traction in the injectable therapies, however manufacturing of it is critical. In this webinar, lets brainstorm on the downstream criticalities of these molecules and how to handle the same. Speaker: |
Risk Mitigation in Cell Line Development: Regulatory Considerations and Impact on Quality AssuranceSubcategory: Cell CultureDuration: 1 hour Date: 7 December, 2021 In this webinar, you will learn about:
Chinese Hamster Ovary (CHO) cells are the preferred host for producing biotherapeutics where cell line development (CLD) is the foundation of the bioprocess. CLD processes are expected to be robust while meeting a myriad of regulatory requirements. The choice of production cell line, culture conditions, and having a chemically defined (CD) CLD process by using CD cloning media can impact the subsequent measures for the CMC (Chemistry, manufacturing, and controls). In this presentation, we will discuss these choices and their impacts on subsequent bioprocess and CMC testing required by regulations and the benefits of incorporating CD cloning media into the CHOZN® expression platform. Speakers: |
Subcategory: Chemicals and Raw Materials |
Business Continuity Management: Principles and Lessons Learned from the Benzonase® Success StorySubcategory: Chemicals and Raw MaterialsDuration: 1 hour Date: 18 April, 2024 In this webinar, you will learn:
Business Continuity Management is a key success contributor to the pharma industry. As industry leader, we will share our BCP principles for a safe and robust supply chain. Analysis from the Benzonase® Business Continuity Plan and Safety-Stock Build-Up Strategy 2019-2023 will also be discussed as an example. Indeed, during Covid-19, more than 2 Billion of vaccines doses were manifactured using this product family. This would not have been possible without a multi year planning strategy. We'll describe why this product has one of the strongest supply chain in the industry. Speakers: |
AAV Process Intensification Using High Salt Lysis & Benzonase® Salt Tolerant EndonucleaseSubcategory: Chemicals and Raw MaterialsDuration: 1 hour Date: 26 October, 2023 In this webinar, you will learn about:
Attention all Cell & Gene Therapy Experts! A New Benzonase® is Born. Do you find challenging to remove HcDNA and chromatin stuck with AAV capsids after cell lysis? To overcome one of the main challenges of the gene therapy industry, we engineered our new Benzonase® Salt Tolerant Endonuclease Emprove® Expert. This new Benzonase® was developed to remove residual host cell and plasmid DNA under high salt lysis conditions where classical endonuclease enzymes are inactive. In this webinar we will demonstrate the enzyme efficiency and showcase its compatibility with detergents used for HEK293 and Sf9 cell lysis, like our Deviron® portfolio. Join us to move your AAV process to the next level. Speakers: |
Managing Nitrite Impurities: A Combined Supplier-Manufacturer View to Nitrosamine RisksSubcategory: Chemicals and Raw MaterialsDuration: 1 hour, 14 minutes Date: 28 September, 2023 In this webinar, you will learn:
The presence of nitrites in excipients evolved as a hot topic among regulatory agencies across the world. This Nitrites in excipients are seen as a risk factor to form nitrosamines in the presence of vulnerable amines during drug product manufacturing process and storage. Health Authorities worldwide imposed recalls to drug products. Our data indicate that the presence of nitrosamines in pharmaceuticals is likely more prevalent than originally expected. This webinar will review the current regulatory considerations, the role of nitrites, the analytical controls. The view of a drug product manufaturer on the related risk mitigation strategy and a case study on risk mitigation is presented. Speakers: |
Deviron® C-16, a Sustainable Replacement to Triton™ X-100Subcategory: Chemicals and Raw MaterialsDuration: 47 minutes Date: 9 August, 2023 In this webinar, you will learn:
Virus inactivation is critical in purification of Biotherapeutics. Triton™ X-100 is most used detergent for virus inactivation in monoclonal antibodies, plasma industry and for bacterial cell lysis. However, Triton™ X-100 has been categorized as hazardous chemical due to its strong endocrine effects after it biodegrades and has got attention to be prohibited for manufacturing by European regulation (REACH). Considering REACH recommendations and health concerns, Merck has limited production of Triton™ X-100 with authorization from REACH and would discontinue over a period. To provide an alternative and help existing users of Triton™ X-100, Merck has developed DEVIRON® C16, a sustainable product to replace Triton™ X-100. DEVIRON® C16 has shown great performance and is as effective as Triton™ X-100 in the inactivation of viruses. Speakers: |
Managing Endotoxins - Detect, Prevent, RemoveSubcategory: Chemicals and Raw MaterialsDuration: 1 hour, 17 minutes Date: 20 July, 2023 In this webinar, you will learn:
Endotoxins are heat-stable lipopolysaccharide (LPS) and a component of the exterior cell wall of gram-negative bacteria. Bacteria shed endotoxin in large amounts upon cell death and when they are actively growing and dividing. Since endotoxins are pyrogenic in mammals, to ensure the safety of a patient, endotoxin content in the drug should always be controlled. Speakers: |
Material Attributes of Poloxamer 188 Affecting the Application in Cell Culture and Liquid Protein FormulationSubcategory: Chemicals and Raw MaterialsDuration: 1 hour Date: 6 June, 2023 In this webinar, you will learn:
Poloxamer 188 finds wide application in the development and manufacturing process of pharmaceutical drug products. In liquid protein formulations, Poloxamer 188 (PLX188) is added to stabilize proteins against mechanical stress, ensuring the desired therapeutic activity and safety of biologics. In cell culture media, PLX188 is added as shear stress protector to prevent cell damage during the cultivation in bioreactor and guarantee optimal cell growth. We will show how the performance of PLX188 in these applications can be affected by variations in molecular weight or hydrophobicity, observed among different batches or products. Speakers: |
CHO Fed Batch Process Simplification using Cellprime Growth Factors and Innovative ChemicalsSubcategory: Chemicals and Raw MaterialsDuration: 41 minutes Date: 2 May, 2023 In this webinar, you will learn:
CHO cell culture media provides all the nutrients like amino acids, buffers, growth fatcors, vitamins and lipids which are required for cellular growth and metabolism. Growth factors like insulin and insulin analogues are critical for cell growth, proliferation and to achieve higher productivity. CHO cell culture media provides all the nutrients like amino acids, buffers, growth fatcors, vitamins and lipids which are required for cellular growth and metabolism. Growth factors like insulin and insulin analogues are critical for cell growth, proliferation and to achieve higher productivity. Speakers: |
The use of Meglumine within the Developability Classification System and BeyondSubcategory: Chemicals and Raw MaterialsDuration: 1 hour Date: 7 March, 2023 In this webinar, you will learn:
The Developability Classification System (DCS) is a modification of the well-established Biopharmaceutics Classification System (BCS) that focuses on the underlying reasons of poorly soluble compounds: Dissolution rate limitations (DCS IIa) and solubility limitations (DCS IIb). By using the DCS we will focus on how Meglumine, an amino sugar, can support in solving challenges with poorly soluble compounds as well as API stability and how it can be used in advanced manufacturing technologies such as hot melt extrusion (HME). Speakers: |
How to Improve API Solubility by Salt and Cocrystal FormationSubcategory: Chemicals and Raw MaterialsDuration: 1 hour Date: 22 November, 2022 In this webinar, you will learn:
Development of new active pharmaceutical ingredients (APIs) is lengthy and cost-intensive, thus avoiding any potential risk that may limit the product's success is of utmost importance. Today, many APIs are not being commercialized as they are poorly water soluble (BCS class II and IV) and, as a result, exhibit too low bioavailability. Diverse API processing techniques have evolved to be chosen from to improve drug solubility, but also stability and processability. Learn in which cases salt or cocrystal formation are your techniques of choice, how to find the right coformers for your API, and how to avoid the obstacles: so that you can care about commercialization, not solubilization. Speakers: |
Arcofolin® - Why the Form of Folate MattersSubcategory: Chemicals and Raw MaterialsDuration: 1 hour Date: 11 November, 2022 In this webinar, you will learn about:
Folate is an essential B-vitamin and, as such, indispensable for many dietary supplements. Low levels of folates are associated with a number of disorders, such as anemia, neural tube defects, and depression. Fortification of foods with synthetic folic acid eliminated severe folate deficiency, but folate insufficiency is still widespread and has also been linked to aging-associated diseases. Synthetic folic acid can also lead to unmetabolized folic acid in blood and as such has been associated e.g. with cancer. In contrast, Arcofolin®, unlike synthetic folic acid, is nature-alike and a directly bioavailable source of folate. This next generation folate has a faster absorption, does not need to be metabolized by the liver, and is more efficient in boosting plasma active folate levels than folic acid. Speakers: |
How to Select Optimum Preservative for Liquid FormulationSubcategory: Chemicals and Raw MaterialsDuration: 1 hourm 15 minutes Date: 25 October, 2022 In this webinar, you will learn:
Preservatives are unique set of excipients which have critical role to protect degradation of formulation from microbial contamination and prolong shelf life of formulation. Ideal preservative should be non-toxic, inert, compatible, wide-microbial activity etc. Selection of preservatives is very critical task because it depends upon multiple factors like route of administrations, pH of formulation, type of formulation, toxicity, compatibility with other excipients etc. Speakers: |
How to Accelerate and Enhance ADC TherapiesSubcategory: Chemicals and Raw MaterialsDuration: 1 hour Date: 21 April, 2022 In this webinar, you will learn about:
The ADCore product line offers versatile intermediates that simplify the synthesis of common ADC payloads (dolastatins, maytansinoids, and PBDs) by greatly reducing the number of synthetic steps. This translates to savings in development and manufacturing costs and shorter timelines to the clinic. To address the poor solubility of many ADC payloads, ChetoSensar™ was developed to significantly increase the hydrophilicity of the drug linker, which has been shown to also substantially increase the efficacy of ADCs and broaden the therapeutic window. Lastly, the ADC Express™ service leverages conjugation chemistry and analytical expertise to help design and quickly synthesize sets of potential ADC therapies suitable for screening to simplify candidate selection and get ADC therapies to market faster. Speakers: |
2021 Virtual PEG SymposiumSubcategory: Chemicals and Raw MaterialsDuration: 2 hours Date: 17 June, 2021 During this symposium, you will:
This technical symposium is a unique opportunity to discover enabling technologies and today's trends in the broad field of pharmaceutical PEG applications, development, and processing. Industry experts will present the latest progress in activated PEGs and conjugation chaired by Lisa McDermott from the Life Science business of Merck KGaA, Darmstadt, Germany. Speakers: |
Subcategory: Downstream |
Intensified and Faster Processing of Chromatography Unit Operation by Membrane ChromatographySubcategory: DownstreamDuration: 1 hour Date: 8 October, 2024 In this webinar, you will learn:
Membrane chromatography is a technique which can be utilized for initial capture steps all the way through polishing. Join us for a webinar exploring the latest developments in chromatography and applications of membrane chromatography in Bioprocessing. This technology has emerged as a powerful tool for improving efficiency and productivity in protein purification for biopharmaceutical manufacturing. Speakers: |
Collaborative Bioprocessing: Next-Gen mAb Downstream Manufacturing Enhanced by Transcenta PartnershipSubcategory: DownstreamDuration: 1 hour Date: 27 June, 2024 In this webinar, you will learn:
The bioprocessing industry has identified an urgent need to intensify downstream operations, making them smaller, faster, and more cost-effective. While numerous technologies and techniques exist to intensify individual unit operations, implementing an integrated next-generation bioprocess presents significant challenges. Our collaboration with Transcenta has culminated in the development of a state-of-the-art, highly automated bioprocessing train for the manufacture of monoclonal antibodies and other biologics. This webinar will detail the bioprocessing template, operational paradigm, and the complexities involved in qualifying such an advanced manufacturing method. Speakers: |
Holistic Approach to Optimize Viral Vector HarvestSubcategory: DownstreamDuration: 1 hour Date: 4 July, 2023 In this webinar, you will learn:
Viral vectors have been a game-changer in the biomedical industry. However, the feed streams for viral vector manufacturing has introduced major harvest challenges, due to the character of viral vectors and its manufacturing process. This webinar addresses an overview on the aspects and the unique challenges around viral vector harvest, from detergent candidates and DNA digestion optimization, to key points in designing clarification and purification at the downstream process. By addressing such points, this webinar would give you some fresh insights on viral vector harvest step. Speakers: |
Process Development and Intensification for Ultrafiltration/Diafiltration of Viral VectorsSubcategory: DownstreamDuration: 1 hour Date: 29 June, 2023 In this webinar, you will learn about:
Fast and efficient processes with reliable scale-up capabilities are essential for viral vector manufacturing. The primary tangential flow filtration (TFF) step - through ultrafiltration and diafiltration (UF/DF) - can intensify the purification process prior to chromatography steps. We will explore two operating strategies, transmembrane pressure (TMP) and permeate control, while considering their impact on process time, viral yield, and impurity removal. We then compare performance of commercially available single-use TFF modules for processing viral vectors. These insights offer a foundation for process development and optimization of processing viral vectors. Speakers: |
How will ICH Q5A(R2) Affect the Design of Virus Clearance Studies?Subcategory: DownstreamDuration: 1 hour Date: 28 February, 2023 In this webinar, you will learn:
Since its issue in 1999, ICH Q5A(R1) has been one of the key guidelines that shaped the design of virus clearance studies for recombinant protein products. ICH Q5A(R2), published September 2022, includes a number of updates that may impact the design of virus clearance studies in the future. Key aspects driving these changes use new manufacturing technologies such as continuous processing and new modalities, including cell and gene therapy vectors. This webinar will discuss the updates and review aspects using alternative virus spiking approaches to address clearance for continuous chromatography and how to build virus reduction capacity into the manufacturing process of viral vectors. Speakers: |
How Updates to EU GMP Annex 1 Impact Sterilizing Filtration in Single Use SystemsSubcategory: DownstreamDuration: 1 hour Date: 2 February, 2023 In this webinar, you will:
The recently published revision to Eudralex Vol. 4 Annex 1, clarified current expectations for manufacture of sterile medicinal products in light of improved process understanding and advances in processing technologies. This webinar will summarize important elements of this revision and highlight how in single use filtration systems can contribute to a holistic contamination control strategy helping drug manufacturers meet regulatory expectations. Speakers: |
Vaccine Journey Bench to Market - Day 2Subcategory: DownstreamDuration: 2 hours, 17 minutes Date: 18 January, 2023 In this webinar series, you will learn:
Vaccine is entering a new era, and we would like to share some insights regarding to the market trends, projection, challenges, and potential solutions around future vaccine manufacturing topic. We would also discuss about the cost for vaccine manufacturing in both traditional and novel platforms. Finally, we would like to share a topic on how Quality by Design is applied in vaccine manufacturing, the principles, the application with case studies with special feature in TFF technologies, and last but not least, the scale up consideration using the QbD concept. Speakers: |
Vaccine Journey Bench to Market - Day 1Subcategory: DownstreamDuration: 2 hours, 23 minutes Date: 17 January, 2023 In this webinar series, you will learn:
You will hear from all Key Opinion Leaders in the field, explaining a fascinating story behind the scene for COVID-Vaccine development, starting from key elements and considerations of Technology transfer in all aspects, to the long-term collaboration in a neglected tropical disease vaccine platform optimization, and how it later transformed into the COVID-vaccine candidates when the pandemic hit. The more to come is the after-tech-transfer stories, how the research results evolved into global collaborations, and what challenges did the receiving parties encountered, how did they solve the challenges, and finally brought to market with real-world COVID-vaccine product, the first Indonesian Homegrown Halal-certified Covid-vaccine - Indovac. Speakers: |
Collaboration to Develop Modular Facility Proof-of-Concept for Multi-Modal Bioprocessing ActivitiesSubcategory: DownstreamDuration: 1 hour Date: 1 December, 2022 In this webinar, you will learn:
Gains in speed, flexibility, and agility are essential for drug and vaccine manufacturers. One innovative solution is the design and construction of manufacturing facilities using predesigned and prefabricated elements. These modular facilities respond to global demand for new medicines while overcoming the lack of predictability and flexibility that have historically burdened manufacturers. This webinar describes the collaboration of our company and G-Con to develop a proof-of-concept facility design that enables multi-modal bioprocessing, including our process equipment, with greater flexibility and response time and facilitates tech transfer and future expansion. Details about the design, timelines, and costs will be included. Speakers: |
Leveraging Traditional Chromatography Techniques for Downstream Purification of Novel ModalitiesSubcategory: DownstreamDuration: 1 hour Date: 14 April, 2022 In this webinar, you will learn:
Novel modalities such as adeno-associated virus (AAV), lentiviral vectors (LVV) and plasmid DNA (pDNA) are gaining prominence with clinical experience and commercialized treatments. A key barrier in bioprocessing of such complex molecules is in the downstream chromatography step where improving process recoveries and efficiencies remain top priorities. Could we leverage well-established, traditional chromatography steps using chemistries such as ion exchange (IEX) to de-bottleneck and streamline the purification of these newer therapies? Learn how to implement chromatographic techniques using resin or membrane formats in your viral vector or pDNA processes. Speakers: |
Effective and Efficient Design of a Downstream Purification Process for Plasmid DNASubcategory: DownstreamDuration: 1 hour Date: 24 March, 2022 In this webinar, you will:
Plasmid DNA (pDNA) is an important component of mRNA, vaccine, and viral vector therapies. Scaling and optimizing downstream processes during manufacturing requires an in-depth knowledge of all unit operations. This webinar presents a design for a generic manufacturing template which overcomes the challenges associated with the purification of pDNA i.e high viscosity, large molecule size, shear sensitivity, and similarities with impurities. Key considerations for purification unit operations include harvest, lysis, clarification, tangential flow filtration, chromatography to sterilizing grade filtration. The webinar presents a comprehensive case study encompassing all downstream unit operations. Speakers: |
Viral Clearance - Something Went Wrong, What do I do Now?Subcategory: DownstreamDuration: 45 minutes Date: 3 March, 2022 In this webinar, you will learn:
We will discuss potential issues that can arise during viral clearance study design and execution and strategies to mitigate certain risks. Even the strongest study design may encounter issues with sufficient clearance to reach the target safety expectations. Join us to learn how to troubleshoot these and manufacturing deviations that impact viral safety. Speakers: |
Get Proactive With Your Stability ProgramSubcategory: DownstreamDuration: 45 minutes Date: 9 December, 2021 In this webinar, you will learn:
To ensure product safety and enhance understanding of product attributes, careful study of the effects of environmental conditions on your mAb is required throughout all phases of development. Long and short-term stability studies are a critical part of a product development program and required by ICH guidelines. However, stability programs require extensive preparation and without this proper planning you may face additional hurdles. Join our experts, Drs. Greg Pirozzi and Pamela Hamill, in a panel style discussion to learn how to proactively plan and execute a testing program to assess changes in stability that may impact product purity, potency and safety. Speakers: |
Payload Core Product Line Accelerates ADC Clinical TimelinesSubcategory: DownstreamDuration: 50 minutes Date: 2 December, 2021 In this webinar, you will learn:
Dolastatins are antimitotic peptides which exhibit highly potent cytotoxic effects in cancer cells. Due to their pronounced antitumor effects, dolastatins have demonstrated clinical success as payloads for ADCs. However, innovators still face numerous challenges when developing and manufacturing ADC therapies, leading to increased costs and delayed timelines. Our core product line aims to address these challenges. DOLCore™ product is a versatile and advanced intermediate that can simplify the synthesis of dolastatin payloads by reducing the number of synthesis steps from 15-20 to four or fewer. The value of DOLCore™ translates to significant savings in development and manufacturing costs driven by risk reduction in payload synthesis and avoidance of supply chain disruption. Speakers: |
The Viscosity Reduction Platform: Enabling Subcutaneous (subQ) DeliverySubcategory: DownstreamDuration: 1 hour Date: 7 October, 2021 In this webinar, you will learn about:
Subcutaneous (subQ) administration can improve patient convenience and reduce healthcare costs by avoiding the need for hospitalization. Yet in some cases, high protein concentrations make formulations far more viscous, prohibiting this route of administration. While viscosity can normally be reduced by using certain excipients, merely adding more and more of a single excipient may not bring sufficient improvement and can even compromise protein stability. This webinar will introduce an excipient platform that makes it possible to combine excipients in ways that can reduce protein viscosity to a greater extent. Speaker: |
Keeping the (Adventitious) Virus Out of the (Adeno-Associated) VirusSubcategory: DownstreamDuration: 1 hour Date: 12 August, 2021 In this webinar, you will learn about:
How do you define a strategy for viral clearance for a process that inherently aims at purifying a virus? Gene delivery using AAV has received a boost from two major approvals and the nearly 300 programs in the clinic. Novel gene therapies using viral vectors enable companies to transform the lives of people living with certain rare and ultra-rare diseases where treatments are often not available currently. Amongst a multitude of challenges in viral vector bioprocessing, uncertainty in regulatory expectations is a major challenge to gene therapy developers. Regulatory requirements are evolving as the science and manufacturing matures with more stringent measures for viral safety assurance expected for future approvals. Learn how to implement techniques for adventitious virus removal in your viral vector process; we will focus on strategies for viral clearance along your journey towards commercial readiness of AAV-based processes. Speaker: |
Make it Right: Best Practices for mRNA ManufacturingSubcategory: DownstreamDuration: 1 hour Date: 8 July, 2021 In this webinar, you will learn:
How do you define a strategy for viral clearance for a process that inherently aims at purifying a virus? The success of mRNA-based COVID-19 vaccines has created a significant level of interest in this versatile biomolecule for disease prevention and treatment. While production of these vaccines took place in record time, critical decisions must be made when developing novel mRNA applications to ensure manufacturability, reproducibility, and safety. This webinar will explore foundational elements of the mRNA manufacturing workflow and strategies to design the right facilities to ensure success. Topics include collaborative approaches to ensure access to high quality raw materials, application of advanced technologies for manufacturing, options for facility design and key considerations when leveraging a contract development and manufacturing partner. Speakers: |
Single-Use Tangential Flow Filtration for Closed ProcessingSubcategory: DownstreamDuration: 1 hour Date: 6 May, 2021 In this webinar, you will learn:
Closed processing with single-use technologies is a critical enabler for efficient and robust manufacturing for novel modalities as well as continuous biomanufacturing processing. It can also reduce the dependence on classified clean rooms for traditional modalities. This approach helps to mitigate the risk of contamination by adventitious agents while enhancing operator safety. In this presentation, we discuss the implementation of closed processing for downstream applications and present the design and performance testing of a single-use manufacturing-scale tangential flow filtration system to be able to operate in both functionally and fully closed mode. Speakers: |
Subcategory: Formulation |
Polyvinyl Alcohol: One Polymer, Multiple Solutions for Oral Solid DosagesSubcategory: FormulationDuration: 1 hour, 30 minutes Date: 15 January, 2024 In this webinar, you will learn:
During formulation development of oral solid dosage forms, complex challenges such as instability of APIs and API processing are on the rise. Due to its various functionalities the multi-talent polyvinyl alcohol (PVA) offers effective solutions to these challenges. Beyond classical applications as a matrix polymer or coating component, the versatile polymer can be effectively used in orodispersible films and is well suited for hot melt extrusion, spray drying, continuous manufacturing and 3D printing technologies. This webinar provides you with technical insights on how PVA can be used in a broad range of solid applications to meet future trends in formulation development. Speakers: |
Thermostabilizers: Protecting Vaccines Upon Cold Chain BreaksSubcategory: FormulationDuration: 36 minutes Date: 5 October, 2023 In this webinar, you will learn:
The delivery of liquid and solid vaccine formulations to developing countries entails several challenges, one of which being cold chain breaks. Short-term exposure to higher temperatures of up to 50 to 80°C results in a large proportion of these vaccines to be wasted each year. It is in the interest of patients and manufacturers alike as the latter faces the financial risk of wasted vaccines. Additionally, approval of new vaccines is restricted due to the pressure on the supply chain. Therefore, we asked ourselves: How can we stabilize protein vaccines in liquid and solid formulations towards these temperature increases using conventional and new excipients? Speakers: |
Envisioning New Concepts for Pharmaceutical 3D Printing and Solubility EnhancementSubcategory: FormulationDuration: 1 hour Date: 26 September, 2023 In this webinar, you will gain:
In this webinar, we will introduce a new concept for additive manufacturing of challenging oral dosage forms. Combining Aprecia's commercial-scale 3D printing platform with our latest solubility enhancement technolgy we are envisioning new manufacturing opportunities for formulation developers. Especially in cases where polymorphism or particle properties are inconsistent throughout development, our technology based on Parteck® SLC silica carrier can provide a new manufacturing alternative by creating 3D printed oral solid dosage forms either utilizing pre-loaded carrier material of by direct loading of the carrier during the 3D printing process. Speakers: |
How to Prevent Protein Aggregation through Stabilizers and SurfactantsSubcategory: FormulationDuration: 1 hour Date: 31 August, 2023 In this webinar, you will learn:
Aggregation of therapeutic proteins can occur during all steps of drug product manufacturing and handling. One option to efficiently prevent protein aggregation in solution is the application of excipients. Depending on the underlying mechanism of protein aggregation, different classes of excipients such as stabilizers and surfactants are required to stabilize the protein. Stabilizers enhance protein stability in the bulk whereas surfactants efficiently prevent agitation- and surface-induced protein aggregation. This webinar will provide a comprehensive overview of protein aggregation, underlying mechanisms and stabilization techniques using (novel) excipients in parenteral formulations. Speakers: |
Strategies and Enabling Technologies for Enhancing API SolubilitySubcategory: FormulationDuration: 1 hour, 34 minutes Date: 4 April, 2023 In this webinar, you will learn:
Development of new active pharmaceutical ingredients (APIs) is lengthy and cost-intensive, thus avoiding any potential risk that may limit the product's success is of utmost importance. Today, many APIs are not being commercialized as they are poorly water soluble and, as a result, exhibit too low bioavailability. The Developability Classification System was developed to assist formulation scientists by introducing two new compound categories: Dissolution rate limited (DCS IIa) and solubility limited (DCS IIb). Depending on where your API lies, there are various strategies to optimize formulation of poorly soluble molecules - From particle size reduction, to solid state modification, to API processing techniques like salt and cocrystal formation. Speakers: |
Envisioning New Concepts for Pharmaceutical 3D Printing and Solubility EnhancementSubcategory: FormulationDuration: 1 hour Date: 30 March, 2023 In this webinar, you will learn:
Covid-19 vaccines have demonstrated the clinical potential of mRNA-Lipid Nanoparticle formulations. To enable the development of next-generation lipid-based drug delivery systems, expertise and manufacturing capabilities are critical. Relying on more than 20 years experience in GMP lipid/LNP manufacturing, we aim at supporting pioneers in nucleic acid modalities to bring life changing medicines from preclinical to commercial manufacturing. Speakers: |
Formulation and Predictive Technologies to De-risk Solid-state Variation in Drug DevelopmentSubcategory: FormulationDuration: 1 hour Date: 15 November, 2022 In this webinar, you will learn:
This webinar will present the concepts of crystal structure and polymorphism in drug development of Oral solid dosage forms, will introduce CSP as an option to minimize solid-state risks and, finally, will describe how mesoporous silica can be used as a last-resort technology to homogenize a solid form from exhibiting polymorphism. All of the above will be supported by a range of case studies from a diverse and highly relevant chemical space. Finally, we will propose an integrated workflow to combine computational and formulation technologies to optimize the development of orally delivered small molecules. Speakers: |
Overcoming Challenges in Ophthalmic Formulations with Right Quality of ExcipientsSubcategory: FormulationDuration: 1 hour Date: 20 September, 2022 In this webinar, you will gain:
The formulation of ophthalmic drugs must address a unique combination of requirements. In addition to ensuring quality, drug tolerability and fostering patient compliance, formulators must also consider tonicity, viscosity, pH, stability, sterility and microbiological purity. This webinar will address how to overcome common challenges in ophthalmic formulations with selection of right quality of excipients. Our GMP grade excipients are in line with ophthalmic industry standards and needs supported by Emprove® Program. Our Emprove® Program along with the Emprove® Expert portfolio range, combines comprehensive documentation with excellent service, to support risk assessment and qualification for your ophthalmic process. Speaker: |
Discover Excipients to Stabilize Your Biomolecule Formulation Using a SurfactantSubcategory: FormulationDuration: 1 hour Date: 26 July, 2022 In this webinar, you will learn:
A stable formulation is critical to ensure the desired therapeutic activity and safety of biologics. Mechanical stresses during manufacturing and transportation and certain storage conditions can lead to protein destabilization and aggregation. By minimizing interface interactions and increasing solubility, surfactants can stabilize proteins. Polysorbates have been the most widely used surfactants in biologics due to their biocompatibility and low toxicity. However, over the past decade challenges associated with the stability of polysorbates have been encountered. To reduce these quality issues, alternative surfactants, such as poloxamer 188 are considered in biomolecule formulations. Speaker: |
Latest Advancements of Melt-based 3D Printing Technologies for Oral Drug DeliverySubcategory: FormulationDuration: 1 hour Date: 23 June, 2022 In this webinar, you will learn:
The application of polymer excipients in 3D printing manufacturing is usually limited due to the concerns of filament strength, high processing temperature and large scale manufacturing. Latest technology developments are targeting a direct melt deposition to simplify the process and enable a constant and efficient process. Two different processing approaches will be presented. The advanced melt drop deposition, where individual three dimensional geometries can be created by depostition of polymer droplets and the MED® 3D printing technology which allows by precise layer-by-layer deposition to produce objects with well-designed geometric structures. Speaker: |
Dissolution Enhancement of Poorly Soluble Drugs, Guided by the Developability Classification SystemSubcategory: FormulationDuration: 1 hour Date: 24 May, 2022 In this webinar, you will learn:
The Developability Classification System (DCS): A useful tool to optimize formulation of poorly soluble molecules. The DCS was developed to assist formulation scientist by introducing two new compound categories: Dissolution rate limited (DCS IIa) and solubility limited (DCS IIb). For DCS IIa molecules, particle size reduction and an addition of Parteck® PLX as a wetting agent can accelerate the dissolution. For DCS IIb molecules, solid-state modification via hot melt extrusion or carrier particles can be utilized. This webinar will introduce the concept underpinning this emerging field of research, which allows more targeted and optimized formulation development of poorly soluble compounds. Speaker: |
The High Intensity Sweeteners Neotame and Sucralose: Two Ways to Ace the Patient's Taste TestSubcategory: FormulationDuration: 1 hour Date: 26 April, 2022 In this webinar, you will gain:
Mask bitter aftertaste for a sweeter pill to swallow! Patients' compliance and the therapeutic benefit are supported by a pleasant taste of pharmaceutical formulations. With the high intensity sweeteners Neotame and Sucralose, you have efficient tools at hand which are superior to other sweeteners in many aspects:
Tune in to our next webinar! We will present our new toolbox of two high performance sweeteners and focus on aspects of stability, safety, the application in various dosage forms, and market perception. Speaker: |
How a Helium Manufacturing Release Test Increases Integrity Assurance for Single-Use AssembliesSubcategory: FormulationDuration: 1 hour Date: 31 March, 2022 In this webinar, you will learn:
Helium integrity testing is an industry-proven test that detects defects in single-use systems. This sensitive test reduces the risk of leaks or microbial ingress into manufacturing processes so manufacturers can be confident their entire systems, including tubing and connection points, are integral. This is especially critical during freezing, thawing, transportation and storage. This webinar will describe development and validation of the helium integrity test and demonstrate how it can benefit critical single-use process steps. Speakers: |
Continuous Manufacturing - Issues and AnswersSubcategory: FormulationDuration: 1 hour Date: 16 November, 2021 In this webinar, you will learn:
Continuous manufacturing is a major trend in solid dose formulation. It shows economic and quality benefits, however, hurdles and challenges need to be tackled before getting there. This webinar will address these hurdles and challenges as they relate to excipients. We will present how continuous manufacturing lines are set up and the benefits users have experienced from them. Feeding of especially small components of formulation combined with bad flow is a major challenge, as well as having a high number of components leading to many feeders. Our answer to these challenges are threefold: betting on multifunctional excipients, and on premixes, either as finished products or as customized projects. Speakers: |
The Developability Classification System for Poorly Soluble Drug Formulation StrategiesSubcategory: FormulationDuration: 1 hour Date: 2 November, 2021 In this webinar, you will learn:
The developability classification system (DCS) was proposed as a modification of the BCS to assist in formulation of poorly soluble compounds. The DCS introduced two new compound categories: dissolution limited (DCS IIa) and solubility limited (DCS IIb). For DCS IIa molecules, particle size reduction and wetting agents can be considered. For DCS IIb compounds, solid state modification can be utilized. Tune in to our webinar on the developability classification system to learn more about this emerging field of research, which is allows more targeted and optimized formulation development of poorly soluble compounds. Speakers: |
The Role of Polyvinyl Alcohol (PVA) in Ophthalmic FormulationsSubcategory: FormulationDuration: 1 hour Date: 5 August, 2021 In this webinar, you will learn:
Polymers play an important role in ophthalmic formulations. However, it is difficult to select the best grade of polymer which provides the desired viscosity as well as ease in formulation development. This webinar will present case studies and benchmarking of various polymers commonly applied in ophthalmics, highlighting the importance of PVA and providing guidance for best practices to handle this polymer. PVA is a synthetic grade polymer with high batch-to-batch consistency available in different grades, low to high viscosity. It offers great opportunities for ophthalmic formulations as it can be used for different applications like lubrication, viscosity modification, stabilization and sustained release. Speakers: |
Excipients Selection for High Risk FormulationSubcategory: FormulationDuration: 1 hour Date: 25 May, 2021 In this webinar, you will learn:
Polymers play an important role in ophthalmic formulations. However, it is difficult to select the best grade of polymer which provides the desired viscosity as well as ease in formulation development. This webinar will present case studies and benchmarking of various polymers commonly applied in ophthalmics, highlighting the importance of PVA and providing guidance for best practices to handle this polymer. PVA is a synthetic grade polymer with high batch-to-batch consistency available in different grades, low to high viscosity. It offers great opportunities for ophthalmic formulations as it can be used for different applications like lubrication, viscosity modification, stabilization and sustained release. Speakers: |
When Coating Runs Smoothly: Enhance your Coating Process with a new Particle Designed PVASubcategory: FormulationDuration: 1 hour Date: 20 May, 2021 In this webinar, you will learn:
In film coating applications water soluble polymers like polyvinyl alcohol (PVA) take a unique position. PVA can be used in immediate release coatings and provides an exceptional moisture and oxygen barrier. A dedicated particle design allows rapid dissolving times and due to the low viscosities of PVA solutions high solid contents can be obtained leading to a high process efficacy. The webinar will cover coating formulation development as well as novel technologies for characterization of coated tablets that can easily be implemented during production. Optical coherence technology (OCT) and laser scanning microscopy (LSM) can be valuable tools to assess the coating quality. Speakers: |
Subcategory: Next Generation Bioprocessing |
Conquering Bioreactor Process Control: From Cell-Free Optimization to Cell Culture ConfirmationSubcategory: Next Generation BioprocessingDuration: 1 hour Date: 5 September, 2024 In this webinar, you will learn:
As the source of biotherapeutic production, the bioreactor is a crucial step for a successful bioprocess. Bioreactors must maintain precise control of environmental conditions to achieve optimal cell growth and productivity, requiring reproducible control strategies. The technology must be flexible and scalable to deliver consistent results from lab to manufacturing. The Mobius® iFlex Bioreactor was developed to meet these requirements and deliver high performance for any process type, from fed-batch to high VCD perfusion. This presentation will demonstrate the system control capabilities in cell-free and cell-containing experiments, enabling successful upstream process outcomes. Speaker: |
Process Intensification of Monoclonal Antibody Purification ProcessSubcategory: Next Generation BioprocessingDuration: 1 hour Date: 11 April, 2024 In this webinar, you will learn:
Process intensification of mAb purification offers a viable approach to boost productivity with minimal facility modification. This approach can also impart flexibility for handling multiple clinical and commercial programs with varying upstream titers. We will provide an overview of an intensified monoclonal antibody purification process leveraging best in class purification technologies offered by us. We will present harvest preconcentration enabled intensified capture, intensified polishing via flowthrough polishing technologies and intensified drug delivery by leveraging viscosity reduction platform, cassette feed channel designs and Single Pass Tangential Flow Filtration (SPTFF). Speakers: |
Unleashing the Power of Perfusion: CHOZN® GS-/- Cell Line Development for Intensified ProcessesSubcategory: Next Generation BioprocessingDuration: 1 hour Date: 21 March, 2024 In this webinar, you will learn:
It is essential to select perfusion clones during cell line development (CLD) that thrive in the unique environment of intensified bioprocesses. Such clones have high specific productivity (qP), moderate growth rates, and high volumetric titer and yield. Traditional fed-batch CLD selects for clones that perform well in fed-batch, but this performance may not translate to a perfusion process. Here, we highlight the advantage of adopting a perfusion-specific CLD process to create more productive clones and provide an integrated solution for intensified processing using the CHOZN® GS-/- cell line, a suite of best-in-class media, and the Mobius® Breez Microbioreactor system. Speaker: |
Modelisation and Real-Time monitoring of Glycosylation During mAb Manufacturing Process Using Raman SpectroscopySubcategory: Next Generation BioprocessingDuration: 1 hour Date: 7 March, 2024 In this webinar, you will learn:
This webinar presents a unique opportunity to delve into the convergence of cutting-edge technology and bioprocessing. Here, Raman spectroscopy stands out as a game-changer, unveiling the intricacies of glycosylation patterns in real time—an essential element in the manufacturing of monoclonal antibodies. The use case highlighted in this webinar illustrates a methodology for building robust and proven glycan models, enabling real-time monitoring of the glycosylation profile. It opens new doors for tailoring and optimizing glycosylation patterns throughout the monoclonal antibody manufacturing process. Speakers: |
PAT Implementation for ADC & Bioconjugation Processes: Applications and Case StudiesSubcategory: Next Generation BioprocessingDuration: 1 hour Date: 9 November, 2023 In this webinar, you will learn:
With drug developers and manufacturers facing closer scrutiny on product quality than ever before, we as industry leading CDMO are continuously evolving process analytical technology to design robust and cost-effective control strategies and understand more about the characteristics of your ADC or bioconjugate. In this webinar we will discuss pros and cons of in(on)line testing for conjugation process, highlight PATs at different steps and share advancements through case studies for real-time monitoring the reduction and conjugation process by online HPLC. Speakers: |
The Closed Processing Advantage: Optimizing Biopharma FacilitiesSubcategory: Next Generation BioprocessingDuration: 1 hour Date: 31 October, 2023 In this webinar, you will:
Join us for an insightful webinar as we explore the future of biopharma facility design and operations. Discover the key market trends driving the need for single-use, closed processing solutions. Learn how closed processing can help you reduce costs, accelerate time to market, optimize facility utilization, and minimize risks. Speakers: |
Enabling Upstream Intensified Bioprocessing with our New Mobius® iFlex BioreactorsSubcategory: Next Generation BioprocessingDuration: 35 minutes Date: 19 October, 2023 In this webinar, you will learn how our new single-use bioreactor family can help you:
Intensified upstream bioprocesses are being developed to increase productivity while reducing footprint, costs and timelines for manufacturing. The higher cell densities generated by intensification result in increased gassing and mixing requirements, to ensure a homogeneous cell culture environment with effective oxygenation and CO2 removal at all scales. The new Mobius® iFlex bioreactor, was developed with an expanded design space, providing flexibility for a variety of bioprocesses. Impeller and motor designs reach up to 100 W/m3 with <35 second mixing time while maintaining tip speeds under 2.2 m/s and innovative spargers achieve kLa of >50 hr-1. Speaker: |
Monitoring and Quality Control of Cell Culture Media Preparation using Raman SpectroscopySubcategory: Next Generation BioprocessingDuration: 35 minutes Date: 2 March, 2023 In this webinar, you will:
Process Analytical Technologies (PAT) are used to measure Critical Process Parameters (CCPs) which affect Critical Quality Attributes (CQAs). They are therefore particularly interesting for better process knowledge and control. Raman spectroscopy has already demonstrated very good results in real-time monitoring of main parameters of cell cultures. This technology could also be used in other steps of a manufacturing process. In this webinar, we will explore the possibilities of using Raman spectroscopy for quality control of cell culture media preparation. We will discuss the benefits of using this technology at this step and the demonstrated performances. Speaker: |
Closed Concept for Biopharmaceutical ManufacturingSubcategory: Next Generation BioprocessingDuration: 1 hour Date: 29 November, 2022 In this webinar, you will:
Innovations in bioprocessing equipment design and operation are reaping higher efficiency through “closed systems”, a concept largely made possible by single-use systems. These connect unit operations and isolate the process from the environment and operators, enabling shorter processing times, greater flexibility, more efficient site layouts and reduced costs. While widespread adoption has not been attained, COVID-19 has accelerated the industry's consideration of single-use and closed processing. Join us to uncover the benefits and challenges of being closed processing ready in bioprocessing, and understand how this achieves better patient safety and care. Speaker: |
Integration of On-line HPLC as a PAT Tool for CQA Monitoring and Control in BioprocessingSubcategory: Next Generation BioprocessingDuration: 1 hour Date: 17 November, 2022 In this webinar, you will learn:
High-performance liquid chromatography (HPLC) is a proven tool for the analysis of critical process parameters (CPP) and critical quality attributes (CQA) of biotherapeutics. Historically, HPLC has been performed off-line, a process that can take days or weeks to complete. By moving HPLC to the manufacturing floor as an on-line Process Analytical Technology (PAT) tool, relevant data can be accessed in a matter of minutes. In this webinar, we highlight an initial use case demonstrating the utility of on-line HPLC to monitor and control antibody aggregation levels in bioprocessing. The implementation of PAT enables continuous manufacturing and empowers industry progress towards Bioprocessing 4.0. Speaker: |
Utilization of Automated Aseptic Sampling for Accelerated Access to Process and Quality Data in Upstream BioprocessingSubcategory: Next Generation BioprocessingDuration: 45 minutes Date: 27 October, 2022 In this webinar, you will learn:
Innovations in process analytical technologies (PAT) are helping to provide more comprehensive and earlier product and process monitoring and control capabilities. In this talk, we will focus on an automated sampling system and its utilization in perfusion cell culture for upstream process development. We will demonstrate increased frequency of data acquisition for on-line measurement of CPPs and automation of a sample processing workflow to reduce the time to measure CQAs in perfusion cultures. Finally, we will discuss the impact of automated sampling to reduce manual labor, accelerate access to analytical data, and reduce risk in the upstream process. Speaker: |
Integration of Raman Spectroscopy for In-line and Real-time Monitoring of Critical Process Parameters and Quality Attributes in CHO Cell Perfusion Cultivation ModesSubcategory: Next Generation BioprocessingDuration: 1 hour Date: 20 October, 2022 In this webinar, you will:
Process analytical technology (PAT) has been defined by the United States Food and Drug Administration as a mechanism to design, analyze, and control biologic manufacturing processes through the measurement of critical process parameters (CPPs) which affect critical quality attributes (CQAs). The goal of PAT is to have quality built into the process, quality by design (QbD), for better process understanding and control. Raman spectroscopy provides a great potential for real-time and in-situ measurement of relevant cell culture process parameters and product quality attributes. Consequently, upholding the QbD initiative. Speakers: |
Effective Implementation of Multi Column ChromatographySubcategory: Next Generation BioprocessingDuration: 1 hour Date: 28 June, 2022 In this webinar, you will learn:
Multi-column chromatography is a bioprocessing technique where multiple columns are loaded in series and then cycled for elution, regeneration and equilibration. This allows fuller utilisation of the potential resin binding capacity, rapid cycling of much smaller columns and with careful scheduling a continuous elution stream suitable for continuous or connected bioprocessing applications. Whilst very effective at increasing operational efficiency, especially with Protein A primary capture of monoclonal antibodies, this technique does present challenges regarding system design, automation and control due to the increased complexity of the single-use flow path. Speakers: |
CAR-T Manufacturing Innovations that Work - Automating Low Volume Processes and Other Key StepsSubcategory: Next Generation BioprocessingDuration: 1 hour Date: 9 June, 2022 In this webinar, you will:
Automated, fit-for-purpose tools are essential in CAR-T processing to support sustainable manufacturing of clinical and market-approved cell therapy products. This webinar will discuss how the ekko™ Acoustic Cell Processing System uses acoustic technology as a touchless approach to manipulate cells, enabling a modular tool across the CAR-T manufacturing workflow. Typical performance of templated ekko™ System processes for DMSO washout of leukapheresis material, low volume and high cell concentrate for electroporation preparation, and harvest of expanded T cells will be reviewed. This webinar will also give an early glimpse at the ekko™ Select System for unmatched T cell selection. Speakers: |
Leveraging Next Generation Raman PAT Platform for Real-Time Bioprocess MonitoringSubcategory: Next Generation BioprocessingDuration: 1 hour Date: 21 October, 2021 In this webinar, you will receive:
Mammalian cell cultures are widely used as the workhorse platform in the production of biological products such as antibodies or other therapeutic proteins. Deviations of critical process parameters (CPP) in upstream operations can directly lead to physicochemical and biological heterogeneities in the biological expression system and associated critical quality attributes (CQA) in therapeutic products. Hence, Process Analytical Technologies (PAT) represent an enabler to the Quality by Design (QbD) paradigm to generate adaptive processes that can maintain productivity and reduce product quality deviations through the implementation of process monitoring and control sensors. Speakers: |
Platform Technologies to Accelerate Novel Vaccine Development and ManufacturingSubcategory: Next Generation BioprocessingDuration: 1 hour Date: 3 August, 2021 In this webinar, you will learn:
The vaccine industry has undergone a revolution in technology resulting in a variety of novel therapeutic platforms that accelerate development and significantly reduce the duration for process optimization and scale-up. However, challenges in maintaining efficacy and improving process robustness remain. In this presentation, we present a comparison of these novel technologies, discuss key considerations for manufacturing and share selected case studies for platforms such as virus-like-particles, viral vectors, plasmid DNA, and mRNA platforms. Speakers: |
Better Bioprocessing Efficiency Through Centralized OrchestrationSubcategory: Next Generation BioprocessingDuration: 1 hour Date: 13 May, 2021 In this webinar, we will present how orchestration software:
In this talk we discuss how orchestration software improves bioprocessing efficiency through the centralized configuration and management of connected unit operations for process and workflow automation across the plant floor. A browser-based software solution, Bio4C™ Orchestrator software connects to individual unit operations from a centralized orchestration layer for remote access to systems, recipes, reports, user accounts and alarms from a holistic process dashboard.
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Subcategory: Regulatory |
Ahead of the Curve: Applying Cutting-edge NGS Technology within Biologics ManufacturingSubcategory: RegulatoryDuration: 1 hour Date: 17 October, 2024 In this webinar, you will learn:
Next Generation Sequencing (NGS) is not a new technology, however its application in biosafety testing and characterization is more recent. With NGS gaining regulatory acceptance for various testing applications within the biologics space, now is the perfect time to incorporate NGS into your testing programs. This webinar explores how NGS is being used in a cross-functional manner for required regulatory testing and will focus on applications such as: Identity with variant detection, adventitious virus detection, on/off target analysis for gene editors, genetic stability, and AAV characterization. Join us to learn more about this technology and its applications from leaders in the field. Speakers: |
Little Patients, Big Challenges: Developing Pediatric FormulationsSubcategory: RegulatoryDuration: 1 hour Date: 13 June, 2024 In this webinar, you will learn:
In the webinar, you will gain insights in new requirements for the testing of high-risk components on the impurities diethylene glycol and ethylene glycol. In addition, case studies for child-friendly dosage forms will be presented. Speakers: |
Navigating the Regulatory Landscape of mRNA-based TherapeuticsSubcategory: RegulatoryDuration: 1 hour Date: 14 May, 2024 In this webinar, you will:
In recent years, RNA-based therapeutics, particularly siRNA and mRNA-based drugs, have revolutionized the field of medicine. In this webinar, we will delve into the categorization of mRNA-based therapeutics in the European Union and the United States and examine the manufacturing requirements for mRNA drug substances in each region. We will also gain insights into the benefits of these regional differences for mRNA drug product development, stay informed on the latest EU and US regulations impacting mRNA therapeutics, from drug substance to lipid nanoparticle (LNP) formulations. In addition, we will discuss how to stay ahead of the evolving regulatory landscape and discover opportunities for your mRNA drug development strategies. Speakers: |
What Do You Need to Do to Qualify a Single-Use Assembly?Subcategory: RegulatoryDuration: 1 hour Date: 15 February, 2024 In this webinar, you will learn:
Single-use technology (SUT) is well established in all stages of bioprocess manufacturing, including upstream, downstream, and fill/finish unit operations. The implementation of SUT usually starts with development of the user requirement specification (URS). The end users at biopharmaceutical companies work closely with the supplier to select components and assemblies (standard or custom) to meet the application requirements. Single-use qualification and regulatory considerations can include properties such as physical, functional, biological, chemical and sterilization. This webinar will discuss best practices for single use qualification including quality and regulatory documentation. Speakers: |
A Journey Worth Taking - An Easier Path to Process Change ManagementSubcategory: RegulatoryDuration: 1 hour Date: 14 December, 2023 In this webinar, you will learn:
Change management is constant in most biomanufacturing organizations and often avoided due to perceived complexity. While changes are necessary, they can also offer the opportunity to improve process control, efficiency, or costs. In this webinar, we describe a scientific, risk-based approach to change management and a roadmap for biomanufacturers to expedite changes in their post approval processes. Suppliers have extensive product testing information and experience with implementing both process and product changes. By partnering with a collaborative supplier, you can leverage their support to streamline risk assessments and the change management process aligned with ICH Q12 guidance. Speakers: |
Applying Next Generation Sequencing for Adventitious Virus DetectionSubcategory: RegulatoryDuration: 1 hour, 30 minutes Date: 12 December, 2023 In this webinar, you will learn:
Next Generation Sequencing (NGS) technology has taken center-stage on the world platform as suitable alternative methodology to traditional broad virus safety screening in biologically derived products as both the industry and regulators progress initiatives to replace, reduce and refine (3Rs) animal testing. Global industry and interest groups have been working for over a decade to demonstrate suitability of the technology to serve as a primary virus screening method. As a result, NGS based methods have been used for virus detection for many years to ensure the safety of both clinical and commercial products and recent updates to the ICH Q5A virus safety guidance encourage the use of NGS as a replacement for in vivo and in vitro adventitious testing methods. The revised guidelines provide the expectations of a well-validated method that can be used for the detection of known and unknown viruses. In this presentation we will discuss the drivers behind the use of the technology, our approach at the validation of an NGS-based adventitious agent method, and the robust bioinformatic analysis that make it all possible. Speakers: |
Pioneering eData Exchange for Quality and Regulatory Data with StaQRD™Subcategory: RegulatoryDuration: 1 hour Date: 17 October, 2023 In this webinar, you will learn:
Embrace a data revolution with the newly developed StaQRD™ eData Standard, driving supplier selection, risk assessment and agile decision-making. The collaboration of BASF Pharma Solutions and Merck KGaA, Darmstadt, Germany unveils StaQRD™, an innovative eData standard, streamlining transfer of quality and regulatory data. Current challenges of diverse data formats are addressed, ensuring efficiency through universal eData compatibility. Discover a new era of streamlined communication and automation, enhancing industry collaboration. Speakers: |
Nitrosamine Method development Approach Inline with the EMA Guideline Published on 30 March 2020Subcategory: RegulatoryDuration: 1 hour Date: 12 October, 2023 In this webinar, you will learn:
The European Medicines Agency (EMA) initiated a request to Marketing Authorization Holders to identify products at risk of N-nitrosamine formation or contamination and to report the outcome. Several other regulatory agencies started similar approaches. Nitrosamine impurities continues to be a topic of concern among regulatory agencies and manufacturers and this webinar will review regulatory updates on this topic and focus on Method development approach inline with the EMA guidelines. Speakers: |
Refresher on Excipient Regulations and Processes to Facilitate Drug Product Registration in ChinaSubcategory: RegulatoryDuration: 1 hour Date: 15 August, 2023 In this webinar, you will learn:
The registration and co-review process in China and ensuring the use of ChP (Chinese Pharmacopoeia) compliant excipients can appear complex and time-consuming. With years of experience and regulatory expertise in China, we will provide an update on implementation of the excipient co-review procedure and reflect on importance of the same during drug approval process. We will expand upon the process of ChP advocacy and share learnings as we encountered challenges. Finally, we will deep dive into regulatory trends for excipients in China including ICH (International Council for Harmonisation) guidance status and microbial requirements for excipient use in sterile and non-sterile drug products. Speakers: |
Evaluating USP <665> for Extractables testing and reducing animal testing for Biological ReactivitySubcategory: RegulatoryDuration: 1 hour Date: 18 July, 2023 In this webinar, you will learn:
Evaluating Extractables & Leachables and performing a risk based approach is a key step for single-use manufacturing. With USP <665> approval in 2021, transitioning to this new standard is ongoing for polymeric material used in single-use manufacturing. Animal welfare and reducing animal testing is also a key initiative. Biological reactivity testing has traditionally used both in vitro and in vivo methods. With the updates to the USP chapters, positioning cell-based assays of USP <87> and ISO 10993-5 as the primary method for determing Biological reactivity. In this webinar, you will learn about the new and changing compendial methods and what it means for pharmaceutical manufacturing. Speakers: |
How to Leverage the ICH Q5A Guidance to Implement the Next Generation of QC testingSubcategory: RegulatoryDuration: 45 minutes Date: 14 March, 2023 In this webinar, you will learn:
In a short survey of the industry, concerns were raised about uncertainty regarding the implementation and consequent regulatory acceptance. This presentation will discuss the strategies for implementation of NGS and PCR-based tests at different steps of the manufacturing process and the requirements for regulatory acceptance. Speakers: |
Best Practices of pDADMAC Flocculation for a Successful GMP BiomanufacturingSubcategory: RegulatoryDuration: 1 hour Date: 28 March, 2023 In this webinar, you will learn:
High cell density culture is the new standard for the biopharmaceutical manufacturing process, but these feed streams can introduce major clarification challenges, such as high cell-based impurities, which foul traditional depth filters and reduce the capacities on further purification process. pDADMAC is a promising solution, yet its use in GMP biomanufacturing requires clarification. This webinar addresses an overview on key aspects about, Quality by Design (QbD), Design of Experiments (DoE), Risk assessments based on ICH-Q3A and clearance test of pDADMAC use for GMP biomanufacturing, and provide you with a vital mindset to use pDADMAC into your GMP biomanufacturing process. Speakers: |
The Future of Pharma- and Biopharmaceutical AuditsSubcategory: RegulatoryDuration: 45 minutes Date: 4 August, 2022 In this webinar, you will learn:
SARS-CoV-2 showed us that technology supports us during our inspection activity even if on-site visits are not possible. Travel restrictions of various kinds will remain a risk in the future. The use of new technologies has shown that inspections and audits can be carried out despite these restrictions. We will focus on what possibilities the new technologies offer and take a look at the future of inspections and audits. Speakers: |
Regulatory Considerations including Extractables & Leachables for Single-Use ManufacturingSubcategory: RegulatoryDuration: 1 hour Date: 2 August, 2022 In this webinar, you will learn:
SA successful adoption of single use technology in a Biopharmaceutical process largely relies on the confidence in selection of such materials. Understanding the regulatory and industry expectations are important to streamline the implementation and approval process. This presentation will go through the regulatory expectation for single-use manufacturing and demonstrate the key benefits of the Emprove® Program including extractables data generated following the guidelines recommended by BioPhorum (BPOG) and adopting the USP <665> guidance. With a case study, a risk assessment process will be used to evaluate Extractables and Leachables requirements in a typical drug manufacturing process. Speakers: |
Single-Use Systems - A Prerequisite for Closed Processing in Final Filtration and Filling OperationSubcategory: RegulatoryDuration: 1 hour Date: 12 July, 2022 In this webinar, you will learn:
The rapid expansion in biopharmaceutical manufacturing capacity has increased the demand for SUS. Key drivers are flexibility, quick changeover of equipment, and reducing the risk of contamination when operating as closed systems. Join us to learn about regulatory expectations when implementing SUS. Speakers: |
Risk-Based Qualification of X-Ray Sterilization for Single-Use SystemsSubcategory: RegulatoryDuration: 1 hour Date: 5 May, 2022 In this webinar, you will learn about:
The urgent need for life-saving therapies as a result of the global pandemic has reinforced the criticality of flexibility in pharmaceutical manufacturing, including sterilization. The single-use bioprocess industry traditionally has employed gamma irradiation sterilization. X-ray irradiation is being considered as an additional sterilization technology for business and supply continuity. We will share a risk-based qualification testing strategy including Extractables and data generated to support comparability of gamma irradiation and X-ray irradiation as equivalent ionizing irradiation sterilization methods. Speakers: |
EU GMP Annex 1 Draft - Closed System Design Consideration with Single Use SystemsSubcategory: RegulatoryDuration: 1 hour, 12 minutes Date: 26 April, 2022 In this webinar, you will learn:
Biopharmaceutical manufacturing capacities have expanded dramatically which has resulted in an increased demand for single-use systems (SUS) as they have their own advantages. Although SUS are well established in the biopharmaceutical industry there is limited guidance on regulatory expectations. During this webinar we will focus on points to consider assuring sterility and integrity of a single-use assembly, and how collaboration between supplier and end-user can support the overall contamination control strategy of final filtration and filling operation. Speakers: |
Regulatory Talks: Finalization of USP 665Subcategory: RegulatoryDuration: 1 hour Date: 17 February, 2022 In this webinar, you will:
The Principle Scientific Liaison from the United States Pharmacopeia (USP) will clarify details regarding the first compendial general chapter, USP 665, detailing a standard assessment and testing approach for qualification of plastic components and systems used in drug manufacturing. This discussion will focus on the shift to this new approach and the necessity to conduct previous compendial test methods. The expert panel will examine USP 665 in relation to other plastic qualification approaches. This discussion will include details regarding shifting away from USP 661, along with questioning the necessity of other related general chapter methods. Specifically, USP 661.1 and 661.2 will be highlighted, which are typically utilized for material characterization and drug packaging component characterization, respectively. In the end, you will be more confident in understanding what, how and when best to utilize the new compendial USP 665 standard extractables test methods. Speakers: |
Regulatory Talks: Is USP 88, Class VI Animal Bioreactivity Testing Necessary for Plastics used in Manufacturing?Subcategory: RegulatoryDuration: 45 minutes Date: 16 December, 2021 In this webinar, you will:
The Principle Scientific Liaison from the United States Pharmacopeia (USP) will debunk myths regarding the risk of using plastics in pharmaceutical manufacturing systems. The specific test in question is USP 88 Class VI, Biological Reactivity Test performed on animals. The expert panel will discuss this test in relation to other plastic qualification approaches. Based on the thousands of laboratory animals sacrificed and the millions of dollars wasted, USP 88, Class VI can no longer be justified in view of its unproven and questionable suitability to detect contaminants and increase safety. We will conclude with points on why animal testing will be seen by regulators as unwarranted. Speakers: |
Regulatory Experience Sharing: Excipients for use in Lipid NanoparticlesSubcategory: RegulatoryDuration: 38 minutes Date: 4 November, 2021 In this webinar, you will learn about:
Excipients in lipid nanoparticles (LNP) can enhance the drug absorption or delivery and are thus of high interest in various therapeutic fields. However, the unique characteristics also pose regulatory challenges and exceed the authority’s expectations on data compared to other excipients. The purity and safety need to be demonstrated because of their crucial role in the function of the drug product and complex potential interactions with other ingredients or the physicochemical environment, for example. Thus, an overview of the regulatory excipient classification and the associated emerging regulatory challenges are presented for LNP, liposomes, and novel excipients. Speakers: |
Risk-based Approach to Evaluate Nitrosamines and Elemental Impurities from Single-use ComponentsSubcategory: RegulatoryDuration: 1 hour Date: 30 September, 2021 In this webinar, you will:
Residual impurities can potentially be introduced into the biopharmaceutical manufacturing process at a variety of stages. Recently, nitrosamines and elemental impurities have been a concern for regulatory agencies. These impurities originate from various raw materials, process chemicals and manufacturing equipment. Single-use systems (SUS) incorporate a number of plastic components. A key concern related to plastic SUS is potential leachable compounds from contact materials. It’s essential to obtain information on leachables as well as nitrosamines and elemental impurities. This webinar looks into how to evaluate nitrosamine and elemental impurity risk related to SUS and filters. Speakers: |
EU GMP Annex 1 Draft: Implications on Sterilizing Grade Filter ValidationSubcategory: RegulatoryDuration: 1 hour Date: 16 September, 2021 In this webinar, you will learn:
In this webinar we will discuss the implications of the EU GMP Annex 1 draft on the filtration of medicinal products and how this impacts the validation studies. Bacterial Retention Testing is a critical part of the manufacturing validation process and is required by all regulatory bodies worldwide. Using case studies, our experts will explain how the Annex 1 draft is incorporated into the filtration systems validation exercise, specifically for integrity testing & PUPSIT (Pre-Use Post Sterilization Integrity Testing), the selection and justification of the appropriate test organism, and validation implications of single versus multiple use. Speakers: |
PDA Virus Conference Follow Up: What to Expect with ICHQ5A (R2) for mAbs, CGT, and BeyondSubcategory: RegulatoryDuration: 25 minutes Date: 26 August, 2021 In this webinar, we share:
Recent advancements in bioprocessing have supported the accelerated growth of the biopharma industry. In response to these advancements, industry forums have focused on the need to minimize pathogen risk during biologics production amid calls for new process design, technologies, and detection strategies. The upcoming revision of ICHQ5A will include the use of new technologies and viral clearance strategies to also examine cell, gene therapies and newer vaccine paradigms such as virus like particles, subunit proteins, and viral vectors. This webinar will focus on presenting the impact on the industry from these updates. Speakers: |
Upcoming USP 665 - Level of Characterization of Single-Use Systems Today and TomorrowSubcategory: RegulatoryDuration: 1 hour Date: 15 July, 2021 In this webinar, we discuss:
Single-use plastic systems are being utilized more frequently especially for COVID-19 vaccine manufacturing. However, there are issues regarding standardization of quality information that limits implementation efficiencies. One of the challenges is the evaluation of leachables derived from a variety of different plastic components in a timely manner. Since the USP 665 highlights a risk assessment approach with no typical pass/fail limit, approaches to decision-making based on the extractables data package will be reviewed. In addition, we will highlight legacy testing requirements which may not be necessary once USP 665 is implemented. Speakers: |
EU GMP Annex 1 Draft – Implications on Filtration and Single Use TechnologySubcategory: RegulatoryDuration: 1 hour Date: 8 June, 2021 In this webinar, you will learn:
Single-use plastic systems are being utilized more frequently especially for COVID-19 vaccine manufacturing. However, there are issues regarding standardization of quality information that limits implementation efficiencies. One of the challenges is the evaluation of leachables derived from a variety of different plastic components in a timely manner. The Annex 1 “Manufacture of sterile medicinal products” of the EU GMP Guide is currently being revised. A first draft of the revised version was published in 2017 and released for public comment. The second draft as of February 2020 was open for targeted consultation via stakeholders from selected industry organizations. The current Annex 1 draft emphasizes Contamination Control Strategy (CCS) multiple times and as a key consideration. Speakers: |
Subcategory: Software |
There are currently no Software webinars. Please check back soon. |
Subcategory: Upstream |
Driving the Evolution towards Intensified Upstream ProcessingSubcategory: UpstreamDuration: 1 hour Date: 14 December, 2023 In this webinar, you will learn:
In the current paradigm shift and transformation in biomanufacturing for a facility of the future, various approaches are being taken to realize a truly an ecosystem of intensified, connected & continuous processing seamlessly coupled with process analytical technologies (PATs). Intensified upstream processing offer a viable option for improving cell culture productivity enabling many operational benefits like process speed and facility utilization. This presentation will summarize the current challenge and trends of upstream processing and describe the latest approaches for process intensification powered by PATs and Single-Use technology for closed processing. Speakers: |
A Single-use, Scale down, Predictive Solution for Intensified Perfusion DevelopmentSubcategory: UpstreamDuration: 54 minutes Date: 4 May, 2023 In this webinar, you will learn about:
Perfusion is becoming a typical approach to achieving upstream process intensification. The ability to scale down these processes, however, has been limited due to lack of appropriate technologies. Labs cannot run enough bench scale 2L bioreactors with cell retention devices due to resource constraints (skilled labor and facilities) and high throughput systems lack the required perfusion or control capabilities. This webinar describes a new microbioreactor system that fulfills this throughput-performance gap providing single-use, perfusion bioreactors with 2mL working volume that can replicate bench scale perfusion processes at industrially relevant cell densities. Speakers: |
Achieving High Yields in Scalable Xeno-Free Culture Formats with Mesenchymal Stem Cell MediumSubcategory: UpstreamDuration: 1 hour Date: 22 July, 2021 In this webinar, you will:
Optimizing ex vivo cell expansion processes in preparation for clinical use is a critical step in cell therapy manufacturing. Given the curative and lifesaving impacts these therapies can have on patients, overcoming roadblocks with scalability and supply chain, using high quality raw materials are essential for therapeutic access. The GMP-compliant Stemline® XF MSC Medium and cocktail promotes expansion of human mesenchymal stromal/stem cells (hMSCs) to high densities while maintaining cell identity and quality. This product was designed for derivation and expansion of MSCs using xeno-free conditions in planar and microcarrier-based culture platforms, easing the transfer between research, clinical, and manufacturing scale cultures. Speakers: |
Turnkey Solutions for Upstream Cell Culture ProcessesSubcategory: UpstreamDuration: 1 hour Date: 29 June, 2021 In this webinar, you will learn:
Chinese Hamster Ovary (CHO) cells are the preferred host for producing therapeutic proteins however, the development of recombinants is both resource and time-intensive. Feed combinations developed from EX-CELL® Advanced and Cellvento® technologies improve performance process development by not only decreasing the timeline of selecting high-producing clones but also simplifying the process by single feed at neutral pH reducing contamination risk and cell damage caused by alkaline feed. Together with protein-quality supplements, these technologies reduce resources needed for process development thereby increasing the number of molecules that can be evaluated concurrently and enabling speed to market. Speakers: |
Water Purification
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Subcategory: Laboratory Trends |
How to Choose Best Adapted Water Quality for Food & BeverageDuration: 1 hourSubcategory: Laboratory Trends What is the central reagent in the laboratory? Water, of course. Let us help your testing by providing tips for water quality to achieve reliable results. Speaker: |
Lab and Instruments MonitoringDuration: 1 hourSubcategory: Laboratory Trends In this webinar, Maryse Gauthey will describe how a connected water purification system can improve lab productivity and maximize uptime. Abstract: Lab and instrument monitoring can provide real-time insight into the status of your lab environment and equipment. Remote monitoring technology allows lab managers to observe the status of the lab environment and instruments and adjust as necessary. A wide range of lab instruments can be monitored with this technology including thermostats, freezers, analyzers, water purification systems, and many more. Join Lab Manager and MilliporeSigma as we explore the Milli-Q® Connect's remote monitoring capabilities on a range of water purification systems. As an attendee you will learn more about:
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The Importance of Health Authority Compliance within Regulated IndustriesDuration: 1 hourSubcategory: Laboratory Trends This presentation will provide an overview of health authority expectations for those within pharmaceutical, medical device and combination product operations to include manufacturing, environmental monitoring and analytical supporting operations The presentation will include an overview of verification and validation concepts as required by health authorities (U.S. FDA and EU) providing a general overview of approach strategies for validation. Current trend information resulting from recent health authority inspections and field actions will be presented as well as contributing root causes resulting in these observations. Primary focus will be referenced to the EU requirements (EudraLex, Volume 4, Good Manufacturing Practices), ICH Q10 (Pharmaceutical Quality System) and the U.S. FDA guidance for Aseptic Processing and Sterile Manufacturing. Speaker: |
Subcategory: Optimize Your Analytical Results |
Are water contaminants impacting your experimental results? Selecting the best water quality for your scienceDuration: 1 hourSubcategory: Optimize Your Analytical Results In this webinar, Estelle Riché, Global Application Specialist at Milli-Q® Lab Water Solutions Merck KGaA, Darmstadt, Germany, will discuss the importance of adapting the purity of the water you use in the lab to the type of experiment/s you are performing. She will provide concrete examples of the impact of water contaminants on your analyses, and explain how to obtain the best water quality for your work. After watching this webinar you will understand:
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A to Z of Water Systems: From Assured Quality to Zero MercuryDuration: 1 hourSubcategory: Optimize Your Analytical Results Water is a ubiquitous and essential solvent in many laboratories. As modern analytical techniques are becoming increasingly sensitive, they require higher quality reagents, which includes ultrapure water. In addition to ensuring the consistent quality of water delivered to their labs, lab managers may need to consider other system features, including environmental impact, user-friendly design and data management solutions. In this webinar, Dr. Estelle Riche will demystify how laboratory water purification systems work, and explain how you can select the right solution to meet your laboratory's specific experimental needs. At the end of this webinar, you will:
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Selecting the Right Water Quality for Modern Diagnostic Lab ApplicationsDuration: 1 hourSubcategory: Optimize Your Analytical Results Water is a ubiquitous and essential solvent in many laboratories. As modern analytical techniques are becoming increasingly sensitive, they require higher quality reagents, which includes ultrapure water. In addition to ensuring the consistent quality of water delivered to their labs, lab managers may need to consider other system features, including environmental impact, user-friendly design and data management solutions. In this webinar, Anastasia Khvataeva-Domanov will demystify how laboratory water purification systems work, and explain how you can select the right solution to meet your laboratory's specific experimental needs. Abstract: Today, activities of diagnostic laboratories are expanding far beyond classical areas such as immunochemistry, biochemistry, clinical microbiology, and histology to also address issues in toxicology or therapeutic drug monitoring. This growth is characterized by successful adaptation of various analytical platforms for analyses of hormones, drugs of abuse, biogenic amines, neonatal screening, etc. New techniques not only enable measurement of multiple complex analyses simultaneously with a very high level of sensitivity and robustness, but also establish new requirements for analyses with regard to process control, operator expertise, and reagent quality. Speaker: |
Pharma Labs: Getting the Most Out of Your Lab Water SolutionDuration: 1 hourSubcategory: Optimize Your Analytical Results This webinar may help scientists working in the pharmaceutical industry to critically evaluate their current lab water purification solution and discover the optimal solution for their particular needs. Abstract: High purity water is one of the main reagents in pharmaceutical laboratories and its quality plays a critical role in successful analyses. Any contamination present in water may interfere with measured analytes, contaminate the instrument, and finally compromise the analytical data — and also result in time wasted repeating analyses and cleaning/troubleshooting analytical instruments. To avoid these issues, the ultrapure water used in any pharmaceutical lab must be of high and constant quality with a minimum level of contaminants detrimental to analyses. Thus, the practical aspects of ultrapure water quality will be highlighted during this session. In particular, specific characteristics that determine water of high quality, as well as aspects related to water handling in the lab will be discussed in detail with respect to pharmaceutical applications. Pharmaceutical Quality Control laboratories must comply with complex and evolving regulatory guidelines. This webcast will provide the audience with everything they need to know in order to make sure that their lab water purification system is compliant with the guidelines issued by global regulatory bodies. Speakers: |
Subcategory: Sample Preparation |
Selecting the Right Filter for Improved LC and LC-MSDuration: DurationSubcategory: Optimize Your Analytical Results Selecting the right filter is critical for improved LC and LC-MS. Dr Vivek Joshi's webinar will be dedicated to describing the key components for success in LC, LC-MS and HPLC analyses. Speaker: |
Subcategory: Tips and Tricks |
Best Practices for Using a Water Purification SystemDuration: DurationSubcategory: Optimize Your Analytical Results Water is so often used in the laboratory that we may take it for granted. In fact, it should be considered with the same care as other high-purity reagents. See why having a good-quality water purification system in your lab is only the first step. Speaker: |
Solutions for Mass Spectrometry - Tips, Tricks and ApplicationsDuration: 1 hourSubcategory: Tips and Tricks Dr. Stephan Altmaier will identify factors contributing to a potential LC-MS contamination, such as solvents or additive purity and will also describe the interactions of impurities with analytes (ion suppression, adduct formation) and their influence on system performance, sensitivity and limit of detection. This webinar will be of interest to anyone working with mass spectrometry who is interested in increasing system performance. The webinar will help you keep your MS clean and improve system performance, in terms of sensitivity and LOD. Speaker: |
Practical Tips to Get the Most from Your Lab's Water Purification SystemDuration: 1 hourSubcategory: Tips and Tricks Water is the most commonly used solvent in laboratories, yet it is probably the least understood. The purity of laboratory water is an important factor for the optimization of experimental results and can boost productivity. In this webinar, we will share practical tips on how you can get the most out of your water purification system At the end of this webinar, you will:
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Subcategory: Water Purification Basics |
Why Does a Simple Molecule Require Such High Quality?Duration: DurationSubcategory:Water Purification Basics LC—MS instrumentation allows very sensitive analysis but requires high quality reagents, solvents, and ultrapure water. Join this webcast to learn about contaminants present in laboratory water and their effects on applications, as well as different modern water purification solutions that can be tailored for your specific experimental needs. Speaker: |
The Forgotten Variable: Laboratory Water Purity and its Impact on Your ExperimentsDuration: DurationSubcategory:Water Purification Basics Join this exciting and interactive webinar about laboratory water. Learn about the potential impact of water purity on your experiments and how water is purified for use in the lab. You will also receive practical advice about how to obtain the best water quality from your purification system. At the end of this webinar, you will have learned:
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