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Bioassays 2018: Scientific Program
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To view the final program, click here.




Monday, April 16, 2018

Fundamentals of Bioassay
Session Chairs: Jill Crouse-Zeineddini, Amgen Inc., Bhavin Parekh, Eli Lilly and Company and Max Tejada, MedImmune, A member of the AstraZeneca Group

Bioassays play an essential role in development of biologics, guiding process development, formulation development, release testing, establishment of storage conditions, and product shelf life. As such, bioassays are a critical element of the analytical control strategy. Bioassays must be relevant to the mode of action of the biologic, as well as be sufficiently precise and robust to perform appropriately in a QC lab for lot release and stability testing. Successful long-term performance of the bioassay method requires a holistic approach to making sure that all the fundamental elements that contribute to the bioassay system are sound and under control.

This session will focus on the following fundamental themes:
• Use of DoE to optimize bioassays
• Setting phase appropriate acceptance criteria for system and sample suitability
• Strategy for long term monitoring of the potency of reference standards
• Basic considerations of training and transfer

Hosted Lunch

Exhibitor Partner Scientific Showcase
Session Chairs: Helena Madden, Biogen and Sally Seaver, Seaver Associates LLC

We all agree that the measurement of the potency of therapeutic drugs is necessary and challenging throughout all phases of a biopharmaceutical life cycle. What about the tools and logistics that allow us to get the job done? This session will highlight some of the forward thinking and scientific creativity needed to develop the tools we use now and the tools we will use in the future. Exhibitor partners will give short presentations demonstrating unique and practical approaches to the measurement of potency. Advancement of scientific technology and vendor expertise will be emphasized.

Blazing a New Path: Are New Generation Biotherapeutics Giving You a Complex (Bioassay)?
Session Chairs: Thomas Arroll, Seattle Genetics, Inc., Steven Hartman, AbbVie, Inc. and Michael Sadick, Catalent Pharma Solutions

Biotherapeutics are becoming increasingly more complex and diverse, both structurally and functionally. Subsequently, the bioassays used to characterize their mechanisms-of-action are also becoming progressively more challenging to develop. Furthermore, the emergence of cell and gene therapies has required the creation of entirely new approaches and strategies to enable the assessment of product safety and functional potency, as well as the need for more rapid assay output.

Presentations in this session will provide examples of the challenges encountered when developing bioassays for complex biologic therapies and will stimulate discussion of the approaches used to assess the potency of these products. Topics presented and discussed will range from CAR-T therapeutics to bi-specific antibodies.

Exhibitor and Poster Reception


Tuesday, April 17, 2018

Structure Function Assessment for Monoclonal Antibodies and Beyond

Session Chairs: David Cirelli, Pfizer, Inc., Xu-Rong Jiang, AstraZeneca, and Marcel Zocher, Bristol-Myers Squibb Company

Bioassays are broadly used for lot release and stability testing of recombinant and biological drug products. However, bioassays also have an important role in the study of the relationship between the structural attributes of a drug and their potential impact on biological activities. For novel and complex biologic therapeutics, some with multiple mechanisms of action, numerous bioassays may be required to obtain a comprehensive understanding of all potential biological activities. This work occurs in parallel with QC testing and through collaboration with other analytical, bioprocess and pharmaceutical scientists. Knowledge gained through structure-function studies informs process development, facilitates determination of product critical quality attributes, and underwrites an appropriate control strategy that includes specifications. The presentations and discussion panel will explore how, when and why structure-function assessments are performed.

Hosted Lunch

Poster Session

Regulators: What’s On Your Mind?
Session Chairs: Evangelos Bakopanos, Health Canada, Katrin Buss, BfArM, Chana Fuchs, CDER, FDA, and Bruce Meiklejohn, Meiklejohn Consulting

Biological molecules represent a diverse group of molecules of which include: proteins; modified proteins; cells; DNA; RNA; vaccines; and mixtures of molecules. The development and the manufacture of these products is an inherently complex process that may draw on novel or platform technologies, as well as conventional or unique bioassay control strategies. While there are a number of regulatory guidelines for the development of biologics, their interpretation across the industry and between countries varies greatly. As a result, health regulators are faced with the daunting task of reviewing significant numbers of submissions from innovators, biosimilar and bio-better companies each with diverse filing strategy. Regulators see and know a tremendous amount – so what’s on their mind?

This session will include presentations from regulators from various countries describing bioassay case studies that highlight deficiencies in regulatory filings and/or in company practices and the subsequent outcomes. These case studies will include various aspects of CMC including, but not limited to, the use of bioassays during manufacturing, product characterization, product control and stability, and to show mechanism of action, to highlight the regulators’ perspectives on best bioassay practices across the industry. Suggestions about what to do better and what not to do will be discussed. Insights into what regulators are looking for will be gained through the session talks and during an interactive panel discussion workshop.



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