Sterile Filtration Videos & On-Demand Webinars

Oct | 2017

• Presenters: Ashley O’Brien, Manager, VPC Team, Provantage® Lab Services; and Stephanie Ferrante, Associate Director of Biosafety Technology Management
• Abstract

  Filtration of liquids through sterilizing grade filters is a common method for removing microorganisms from small volume parenterals that are heat-sensitive. Final filtration with a 0.22 µm diameter filter is the last unit operation in the process and is a critical step for successful manufacturing. Regulatory requirements and industry best practice offer insight into assuring that this critical unit operation is effective. A comprehensive validation strategy provides the scientific evidence to confirm process conditions and filters are robust, and to defend these decisions to regulatory authorities. The authors will focus on the filter sterilizing step, cite relevant guidance and provide an example of how to assure this critical step is effective for a representative drug product.
  
  In this webinar, you will learn about:

  • The importance of sterilizing grade filters for removal of microorganisms from small volume parenterals
  • Why this last unit operation in the process is a critical step
  • How to make it effective for successful manufacturing
  • How a comprehensive validation strategy can provide scientific evidence to help with regulatory authorities

March | 2017

• Presenter: Dr. Paul Beckett, Technology Manager Life Sciences, EMEA
• Abstract

  The tendency for most biological products to self-associate and aggregate, often irreversibly, is a considerable challenge in process management and design, as aggregated product leads to patient safety concerns, process challenges and lost yield. Therefore, it is important to reduce the aggregation of the biological product during processing and to remove aggregates efficiently and effectively.
  
  In this webinar you will learn:

  • How and why biological product aggregates form within a bioprocessing environment, based on process conditions and biochemistry, and how these are detected
  • Strategies for reducing the risk of aggregation at each stage of the process
  • Proven methods for removal of aggregates effectively

Jan. | 2017

• Presenter: Randy Wilkins, Principal Technical Consultant
• Abstract

  Integrity testing is a critical operation, especially for sterilizing grade filters used in biopharmaceutical processing. When performed correctly, an integrity test is a fast, definitive, non-destructive way to assure filter retention performance. Fortunately, there are few ways a non-integral filter will pass the integrity test, eliminating the possibility a non-retentive filter is used undetected. Unfortunately, there are a lot of ways an integral filter can fail the integrity test, resulting in retests, lost time, productivity and potentially lost product.
  
  In this webinar you will:

  • Gain confidence in your integrity testing results 
  • Provide justification for retests
  • Understand specific challenges and eliminate them to assure the integrity test can be performed correctly the first time

Nov. | 2016

• Presenter: Michael Felo, Director Mobius Single-Use, Merck
• Abstract

  Single-Use systems, enabling faster more cost effective bio-pharma manufacturing, must also meet high quality parameters and standards while conducting component qualification, manufacturing operations, inprocess testing, and final product release.

  For single use systems, quality control during the manufacturing process is critical. In a traditional stainless-steel system, the end user has significant control over the design, construction, qualification and validation, and maintenance of the system. When implementing a single-use system, the supplier of the single use product takes responsibility for many of these functions from the user. It is therefore important that the single use supplier has established and follows a strong quality control system. This presentation will highlight the quality systems, processes, facilities, and personnel required to assure the performance, robustness, and sterility of single use systems.

  In this webinar you will learn:

  • The process used to qualify components, suppliers and sub-suppliers
  • Managing documentation control, change control, process particulate control, risk mitigation practices
  • See examples of Extractables Testing, Validation of MFG processes, MFG Controls, Sterilization Qualification, Realease Testing and Certification, Integrity Assurance

Nov. | 2016

• Presenter: Emily Peterson, Biomanufacturing Engineer, Merck
• Abstract

  Strategies to overcome key limitations and challenges such as higher molecular osmotic pressure and lower membrane permeability when customizing small molecule (3-10 kDa) TFF processing.

  Due to their higher osmotic pressures and mass transfer coefficients, small molecules in the range of 3 – 10 kDa, like insulin, often require unique processing conditions as compared to those of larger molecules. TFF processing strategies developed for larger molecule applications may not be appropriate and can lead to an increase in process variability and sub-optimal performance.

  This webinar explores:

  • The key limitations and challenges typically observed with small biological molecule TFF processing
  • Explains the strategies required for optimal success with your TFF step

May | 2016

• Presenter: Ranjeet Patil, Technology Manager, Merck
• Abstract

  Buffers are widely used across a biologics process and are a large contribution to the COGS. An optimized process is key to an efficient and economic operation. A few key considerations can greatly improve efficiency of buffer operations and ease the transition from small-scale operations to efficient large-scale manufacturing.
  
  In this webinar, we will review important steps in a buffer operation such as raw material selection, mixing, filtration, storage, sampling and testing. With emphasis on filtration, we will review steps to optimize your buffer filtration process to overcome typical challenges that will result in an efficient process.

March | 2016

• Presenter: Sal Giglia, Principal Applications Engineer, Merck
• Abstract

  Sterilizing grade membrane filters are often packaged in pleated formats. A wide variety of pleat configurations are possible including high density pleat geometries that allow for increased productivity per device, smaller filter footprint, and improved filtration economics. In this work, a so-called M-pleat pattern was demonstrated to provide up to 100% more membrane area than a conventional pleat pattern. A high pleat density arrangement can, however, present unique challenges when scaling up from discs to cartridges. Reliable scale-up from discs to pleated devices is possible, but requires a comprehensive understanding of all elements of filter scaling.
  
  In this talk, the factors that impact membrane filter (and in particular high area membrane filters) scalability will be discussed. High area filters are most advantageous for mid to high plugging streams, in which the membrane is the dominant resistance to flow, and resistances external to the membrane are minor. A model was developed for predicting device productivity efficiency as a function of the filtration properties of the filtered stream. This model can be used to assess which applications can most benefit from high area pleated devices and which applications may be best served using conventional pleat configurations.

Jan. | 2016

• Presenter: Kenneth Muzykewicz, Director of Membrane Process and Technology, Merck
• Abstract

  Changes happen. Suppliers go out of business. Plants consolidate. Drug product lifecycles exceed the lifecycles of the raw materials on which they’re reliant. We are committed to controlling, managing and communicating changes in the most stringent and highest quality manner to ensure your security of supply. In this webinar, Kenneth Muzykewicz will provide you with an overview of our change control process for critical raw materials within our filters.

  Join us for this webinar as we will focus on our:

  • Validation strategy & philosophy
  • Step by step approach to validation
  • Success criteria

  And learn how we:

  • Demonstrate no adverse effect on product performance
  • Define equivalence
  • Minimize the impact of change on your process

April | 2015

• Presenters: Thierry Burnouf, Ph.D., Taipei Medical University, Taiwan and
  Eric Youssef, Plasma Market Leader, Europe and Asia, Millipore SAS, France
• Abstract

  Biomanufacturing of plasma-derived products requires at least two orthogonal virus reduction steps to comply with regulatory pathogen safety risk mitigation guidelines. Solvent detergent viral inactivation (SD VI) has historically been effectively utilized for the inactivation of lipid-enveloped viruses from plasma derived products, yet only recently have process development activities focused on implementation of SD VI in single use systems. The adoption of single-use technologies for bioproduction continues to progress, driven predominantly by the benefits of operational flexibility, speed of implementation, lower capital investment, and elimination of cross contamination concerns. However, the suitability of this flexible production platform for SD VI remains to be fully characterized.
  
  This presentation will review data generated on a single-use mixing platform that demonstrates successful performance of this operation in a flexible manufacturing environment. Specifically, chemical compatibility, non-specific chemical adsorption, and leachables profiles of the reagents used in SD VI with the container assemblies will be reviewed. In addition, the effectiveness of inactivation, based on small scale virus spiking studies, will be presented. Finally, the potential impact on protein quality and activity will also be discussed.

April | 2015

• Presenter: Christine Wright, Ph.D., Senior Research Scientist, Merck
• Abstract

  Mitigation of bioreactor contamination risk is complex. People can be lulled into a sense of security that serum-free media eliminates that risk. However presence of contaminants such as mycoplasma can be devastating, leading to extensive investigation and downtime. After attending this webinar you will be able to better scrutinize your process, identify gaps and propose solutions relating to bioreactor contamination mitigation. You will also learn what questions to ask your vendor to make the optimal filter selection and you will be able to conduct an objective comparison of filter claims vs. performance.

Feb. | 2015

• Presenters: Janmeet Anant, Regulatory Advocate and George Adams, Director of Marketing for Provantage® Laboratory Services, Merck
• Abstract

  Investigational New Drug (IND) applications must contain information allowing an assessment of whether or not the product is reasonably safe for initial testing in humans. This typically includes information pertaining to the chemical composition, manufacturing methods, stability, and controls used for manufacturing the drug substance and the drug product. Providing this information for investigational medicines can be more complex where the manufacturing process may not yet be fully defined. Sterilizing filtration should be qualified during early clinical phases to demonstrate that it is effectively providing a sterile product without adversely affecting its properties. The filter, as critical equipment used for manufacturing sterile phase 1 investigational drug, should not contaminate or otherwise react with, add to, or be absorbed by the drug. In order to assess its performance and thereby ensure the quality of the product, several aspects have to be examined including bacterial retention, chemical compatibility, extractables and adsorption. Based on our experience at Merck, you will learn about the key elements of sterile filtration validation, along with understanding more about global regulatory guidance for developmental phase drug products.

Dec. | 2013

• Presenter: Randy Wilkins, Technical Consulting Team Manager, Merck
• Abstract

  Sterile filtration is commonly employed for microbial removal and plays a pivotal role in assuring final product sterility. Where sterility will be claimed, regulatory agencies worldwide require that the sterilizing-grade filter(s) be integrity tested to ensure filter performance is verified prior to and after filter use. Therefore, successful filter integrity tests are a critical link between your filter validation and current processing. This webinar highlights best practices and key considerations for performing filter integrity tests to give you a better understanding of how to design a robust integrity test operation in your own facility.

Nov. | 2013

• Presenter: Ernie Jenness, Senior Product Manager, Merck
• Abstract

  The use of single-use connectors has proliferated with the growth of single-use systems. Connectors are available for non-sterile and sterile applications. Non-sterile include TC style, standard barb connect, and other open device styles, some allowing for ease-of-use when disconnecting. Sterile applications include connections made to stainless steel systems (hybrid) as well as the sterile connectivity within single-use systems. This webinar will explore the applications of non-sterile and sterile connectors within single-use systems. Advantages and disadvantages are reviewed and best practices discussed.

Oct. | 2013

• Presenter: Michael Payne, Technical Biosafety Consultant, Merck
• Abstract

  Aseptic processing is one of the toughest challenges in the vaccine industry. This webinar focuses on sterilizing filtration as a core of aseptic processing, and explains the best practices of process validation to assist compliance to the key regulatory guidelines. We will demonstrate how the combination of process validation and risk assessment contributes to deliver robust compliant aseptic processes especially when applied to sterilizing filtration. During this webinar you'll also learn - the basic concepts behind process validation and aseptic processing - how to define a framework to structure process validation - the foundations of design, installation, and operational qualification - how to apply risk assessment to aseptic processing - the key regulatory guidelines for aseptic process validation - how compliant sterilizing filtration process qualifications contribute to the foundation of aseptic process validations This practical webinar should be of specific interest to companies based in developing nations, where validation resources need careful prioritization. Who should attend? Attendance will be beneficial to personnel from production, quality assurance, validation, technical support and engineering departments who are directly or indirectly involved in process validation.

Sept. | 2012

• Presenter: Ross Acucena, Regulatory Consultant, Services and Solutions, Merck
• Abstract

  Regulations and regulatory guidance for the qualification and validation of sterile filtration processes are specific and well developed. However, specific guidelines regarding the length of time a filter can be used or the number of batches a filter can produce are not well defined. This webinar will provide recommendations for a well designed approach to validating filter use for multiple batches or extended processing time. Join us as we elucidate these guidelines and recommend a practical approach to validation which balances processes efficiency and risk.

June | 2011

• Presenter: Mike Felo, Applications Engineer Consultant, Merck
• Abstract

  Improper vent design can result in low flow rates, frequent change-outs, higher operation costs and increased risk for the application. Fortunately, a proper vent design can be achieved as long as the flow requirements, operating condition, system design and risk levels are understood.
  
  Join us as we highlight best practices and key design considerations for vent filtration applications while reducing costs. Discover how to mitigate common issues encountered in day-to-day vent filtration operations, and learn more about regulatory requirements, risk management considerations and integrity testing.

June | 2011

• Presenter: Mark Blanchard, Research Fellow, Merck
• Abstract

  In aseptic processing of pharmaceutical products, it is critical that drug products are free from bacteria and other microorganisms to ensure patient safety. Sterilizing-grade filters are commonly used to meet this requirement.
  
  Join us as we review different approaches to sterile filtration including: nominal pore size ratings and log reduction values (LRV). We will describe an approach to selecting an effective and efficient sterilizing filter and will show how this approach is in alignment with quality by design (QbD) principles.

June | 2010

• Presenter: Vikas Gupta, Group Product Manager, Downstream Processing, Merck
• Abstract

  The webinar explains the lean manufacturing waste categories in the context of single-use manufacturing. Learn how flexible filtration can meet fast-changing product, site and scale requirements by bringing together ready-to-use, right-out-of-the-box single-use systems, featuring modular, fully optimized assemblies that are simple to set up. These systems use only what is needed, are replicable, scalable and designed to facilitate technology transfer across multiple sites.