Formulation Videos & On-Demand Webinars

Sept | 2017

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

  Improving vaccine purification yield and efficiency with custom TFF membranes.
  
  Vaccines save millions of lives every year and improve the quality of life for countless others. Unlike monoclonal antibodies, a greater diversity of molecular size exists for vaccine products, which makes a downstream process hard to template. In the case of conjugated polysaccharide vaccines, this is further complicated by the fact that a large number of strains and serotypes need to be conjugated into a multivalent vaccine to provide thorough immunity, and each serotype can behave differently during processing. One of the most critical purification steps in a conjugated polysaccharide vaccine process is the removal of unconjugated polysaccharide from the feed stream, which is typically performed via tangential flow filtration (TFF). A continuing challenge for the TFF step is that membranes are available in a limited set of nominal molecular weight cutoffs. This limited availability of specific pore size membranes often leads to yield sacrifices in order to maintain the required purity, which potentially impacts the reliability of vaccine supply. An advancement in the mPES membrane manufacturing process can enable better uniformity and improved control of the membrane pore size. This provides the capability of producing a custom TFF membrane best suited for a given process stream and therefore, enhance yield, purity, efficiency, and economics in new or existing vaccine processes.
  
  In this webinar, we will discuss:

  • Current process development challenges for conjugate polysaccharide vaccines (CPV)
  • How a custom membrane technology can be developed and implemented
  • How an industrial process yield and efficiency were improved with use of custom membranes in a case study

Sept | 2017

• Presenter: Michael Schulte, Head of R&D Chromatography
• Abstract

  This webinar will teach you how to complete a combined and optimized method for the complete downstream processing of recombinant human insulin and select the most suitable phase combinations.
  
  By 2035, 10% of the adult population, a total number of 600 million people worldwide, are projected to suffer from Diabetes. As a result, the demand for recombinant human insulin will increase significantly. The number of projects currently under way for the production of insulin biosimilars reflects this direction. This webinar focuses on the increasing need for recombinant human insulin purification in the downstream process. The capture and intermediate steps of the process use ion-exchange resins, while the polishing step uses high-performance reverse phase silica. The ion-exchange resins in the first steps should have high flowrates combined with high binding capacities as well as very low non-specific binding of process impurities such as pigments from the fermentation broth. For the final polishing step on RP-silica, it is critical to select a suitable combination of stationary and mobile phases since this combination heavily influences selectivity and process throughput. Finally, we will touch upon the use of tangential flow filtration to process the aqueous-organic value fraction during the reversed phase polishing step.
  
  In this webinar, you will learn:

  • How to complete a combined and optimized method for the complete downstream processing of recombinant human insulin
  • How to critically decipher and select the most suitable phase combinations for the process.

Aug | 2017

• Presenters: Jyothi Swamy Ph.D., Head of Global Marketing, ADCs; Josh Morris, Project Manager; and Mark Cooley, Head of Site Quality
• Abstract

  ADC manufacturing presents a unique set of challenges as compared to the well established practices employed for more traditional biologic products.
  
  The development and commercialization of key intermediates, complex small-molecule APIs and biologic drug substances shouldn’t be such a headache. The uniqueness, versatility, and complexity involved in each project only means you need to make sure you’re well informed when it comes to the dos and don'ts of manufacturing commercial Antibody Drug Conjugates (ADCs). Tune in to hear a CMO perspective for an in-depth understanding on the subject of manufacturing commercial ADCs. Our team will discuss all of the considerations that must be addressed to successfully manufacture ADCs.
  
  In this webinar you will learn:

  • Facility Design and Cleaning Validation
  • Advantages of Single Use Systems
  • Process Control and Regulatory Strategies

June | 2017

• Presenters: Eric Lacoste, Head of ADC Process Development Team at Sanofi
• Abstract

  This webinar highlights Tangential Flow Filtration (TFF) case studies during Antibody Drug Conjugate (ADC) process development within Sanofi and provides preliminary results on a novel single-use TFF capsule.
  
  ADC therapies have been a booming field within the last decade, and remain a key possibility for Paul Ehrlich’s vision of a “magic bullet” concept for personalized medicine. However, ADC process development and manufacturing remain very challenging due to the intrinsic complexity of these drug entities.
  
  The generic ADC process is composed of at least three steps: chemical reactions in aqueous buffer (including some organic solvent); purification and formulation steps. This webinar will highlight TFF case studies during ADC purification process development within Sanofi, and will provide preliminary results using a novel single-use TFF capsule. This new device is designed to replace standard TFF cassettes, providing the same level of performance while offering improved process containment.
  
  In this webinar, you will learn:

  • TFF process development
  • Implementation of a TFF capsule instead of cassette

May | 2017

• Presenters: Lisa McDermott,Principal Scientist, Process & Analytical Development & Guillaume Plane, Global Development and Marketing Manager
• Abstract

  This webinar will highlight the advantages when working with one source on your mAb, linker/ payload supplies and conjugation services.
  
  While ADCs represent a promising new type of therapy, the corresponding supply chain of monoclonal antibodies, payloads and linkers presents a significant challenge. This webinar will highlight the advantages when working with one source on your mAb, linker/ payload supplies and conjugation services. We will showcase the accelerators during the journey of the ADC to move from development to market faster. For example, how we manage to process the mAb from cell to clinic within 12 months. And address seamless process and analytical control strategies by integrating linker/payload and conjugation chemistry.
  
  In this webinar you will learn:

  • Advantages of a fully integrated supply chain
  • How to accelerate mAb process development
  • Process control strategies for ADC programs

April | 2017

• Presenter: Prof. Dr. Karsten Mäder, Martin-Luther-University Halle-Wittenberg
• Abstract

  This webinar will discuss critical quality polymer parameters for injectable sustained-release formulations.
  
  Controlled-release formulations of drugs administered through injection help to improve patient comfort and compliance as they reduce the frequency of administrations while providing the same therapeutic efficacy. Using biodegradable polymers, such as PLA and PLGA, the drug release can be controlled and extended over weeks to months. However, for these sustained release formulations, there are a number of critical quality parameters which one needs to be aware.
  
  In this webinar, you will learn:

  • The fundamentals of formulation with PLA and PLGA
  • Critical quality polymer parameters based on the formulation
  • Optimized release through alternative polymer end groups (PEGs)

April | 2017

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

  Overview of available TFF solutions for achieving high viscosity of monoclonal antibodies and plasma IgG, and strategies for reliable cycle-to-cycle cleaning.
  
  Current trends in the bioprocessing industry are driving mAb and plasma producers to formulate at higher protein concentrations. As a result, formulating using tangential flow filtration (TFF) may be limited in reaching these concentrations due to high pressures caused by highly viscous feed streams. Filtration devices used during processing have to be optimized in order to handle both high viscosity and pressures while maintaining high flux and excellent product recovery.
  
  In this webinar, we will review a recent study in which a family of filtration devices was evaluated to characterize the impact of membrane material and channel geometry on process performance and cleanability when working with high concentration feed streams. The results show the performance of each filtration device over multiple re-uses and presents a solution that can overcome process limitations due to high viscosity formulations.
  
  In this webinar you will learn:

  • Options to achieve higher concentration
  • Cleaning recommendations for TFF cassettes used in high viscosity feedstreams
  • Performance comparison between device design in TFF cassettes

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

March | 2017

• Presenter: Dr. Finn Bauer, Director for Solid Formulations R&D, Merck
• Abstract

  This webinar will discuss how to overcome challenges in API solubility and bioavailability by using polyvinyl alcohol as a matrix polymer in hot melt extrusion.
  
  Poor solubility of active pharmaceutical ingredients (APIs) is a critical challenge in oral solid drug development. It is estimated that up to 90 % of drugs in the pharmaceutical pipeline are poorly soluble. For these APIs, an advanced formulation that increases solubility can be the key factor in bringing the drug to market.
  
  One formulation technology to increase solubility and, consequently, improve bioavailability of drugs is hot melt extrusion (HME). It is a solvent-free process that is applicable to a broad range of APIs. With this technology, the API is dispersed, often down to the molecular level, into a polymer matrix to form an amorphous solid dispersion or solid solution. Polyvinyl alcohol (PVA) is a well-established pharmaceutical excipient that provides special functionalities as a new HME matrix polymer.
  
  This webinar will discuss the basic challenges of HME in solubility enhancement combined with stable, high drug loads. Case studies will include data addressing a variety of parameters from extrusion to final formulation, such as API application range, stability of extrudates, and release kinetics.
  
  In this webinar you will learn:

  • Fundamentals of hot melt extrusion for pharmaceuticals
  • Application of PVA to increase API solubility, achieve stable, high drug loads, and expand the application range of HME
  • How to modify the release kinetics in subsequent drug formulations

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

April | 2016

• Presenters:
  
  • Aaron Hammons, Business Development Manager, Drug Delivery Compounds, Merck
  • Dr. Frank Leenders, Chief Operating Officer, celares GmbH
• Abstract

  PEGylation is an established and successful tool for improving the pharmacokinetics (PK) of a drug by extending its therapeutic half-life. Parenterally applied medicines such as innovative biotherapeutics benefit particularly from PEGylation. Since 1990, PEGylated forms of 14 drugs have been launched on the market. Neulasta®, Pegasys®, PEG-Intron®, Cimzia®, and Mircera® are prominent examples of PEGylated products with global annual turnovers of billions of dollars.

  Developing PEGylated drugs require knowledge of both biology and chemistry. With an increasing number of biosimilars and novel products approaching the market, the pressure for process optimization and cost reduction is high. At the same time, PEGylated drugs are expected to be of extremely high quality.

  The webinar addresses critical success factors such as:

  • Strategies for efficient conjugation of PEG to biomolecules
  • Challenges in the purification of PEGylated biomolecules
  • Criticality of raw material quality and specifications

  Neulasta is a registered trademark of Amgen Inc.
  Mircera and Pegasys are registered trademarks of F. Hoffmann-La Roche AG
  PEG-Intron is a registered trademark of MSD Sharp & Dohme
  Cimzia is a registered trademark of UCB S.A.

March | 2016

• Presenters:
  
  • Dr. Adela Kasselkus, Marketing Manager Bioavailability Enhancement, Merck KGaA, Darmstadt, Germany
  • Dr. Gudrun Birk, Head of Controlled Release, Merck KGaA, Darmstadt, Germany
• Abstract

  Modified release formulations offer numerous opportunities, including the possibility to improve the therapeutic efficacy of a drug. There are numerous approaches for modified release, each with its own benefits and drawbacks.
  
  This session discusses various solutions for sustained release formulations, long established as well as new functional excipients which may present an alternative, supported by case studies as well as benchmarking studies.

March | 2016

• Presenter: Dr. Leo Ohrem, Portfiolio Manager Solid Dose, Merck
• Abstract

  QbD (Quality by Design) is of growing importance to the pharmaceutical industry – both for novel drugs and generics. Driven by health authorities worldwide, pharmaceutical manufacturers are under increasing pressure to implement QbD principles and thereby increase control over product quality. This also impacts excipient supply.
  
  This webinar outlines how excipient suppliers can support these QbD efforts. User-supplier cooperation is essential in controlling critical parameters once these have been defined. Defining the design space requires QbD samples – are these available, and what can be done if not? The webinar shows a way out of this trap.

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

Sept. | 2015

• Presenters: Gudrun Birk, Head of Controlled Release, Merck and
  Dr. Alena Wieber, Head of Customized and Oral Formulations, Merck
• Abstract

  Most active pharmaceutical ingredients (API) lack aqueous solubility during pharmaceutical drug product development, and one in three drug candidates offers poor bioavailability (BA) in the preclinical stage. Various strategies are commonly used to enhance drug bioavailability, and carriers can improve the aqueous solubility of drug candidates. Inorganic carriers such as porous silica-based particles are advantageous, as the material is safe (GRAS) and can easily be formulated into a final oral dosage form (tablet or capsule). This webinar discusses the proof of concept and formulation strategy for silica-based drug carriers, exemplified by different case studies of poorly soluble drug candidates.

July | 2014

• Presenter: Dr. Leo Ohrem, Portfolio Development Manager, Merck
• Abstract

  Reducing costs is a constant concern in pharmaceutical production. However, choosing the cheapest raw materials may not be the optimal choice with regards to the overall cost of ownership. In this webinar, we highlight how the proper selection of functional excipients can help reduce overall costs. The webinar discusses stability issues arising from excipient byproducts, which can lead to prolonged development time, as well as mechanical stability of the finished product.
  
  Mechanical stability becomes relevant in large scale operations due to the fact that subsequent handling of a robust tablet leads to less scrap rate in the final quality check. Additionally, excipients with high functionality may enable the formulator to reduce the number of single excipients needed in a formulation. This minimizes time for development and registration as well as risk for further API interaction and reduces costs. Most importantly is to achieve possibilities for direct compression as a process in competition with wet granulation.
  
  This webinar presentation showes how to overcome the most prevalent technical limitations for direct compression including content uniformity, compressibility and flow.