This product is only available to members of the following groups:
Session Speakers:
Meaningful Bioassays to Elucidate Structure-Function and Demonstrate Control
Colleen Santoro, Bristol-Myers Squibb Company
Assay Development and Concept Verification of a Tri-Specific Antibody
Yuri Mizuno, Chugai Pharmaceutical Co., Ltd
Variant Characterization in Bioassay – An Underestimated Step
Daniel Markx, Ingelheim Pharma GmbH & Co. KG
Session Speakers:
Quantifying Endogenous Protein Content to Measure and Control Potency of Antibody-PROTAC Conjugates
Clare So, Genentech, a Member of the Roche Group
Potency Testing Approaches: Challenges and Opportunities for mRNA Therapeutics
Jan Falcke, BioNTech SE
Modular Application of Automated Liquid Handling
Alissa Sheils, Amgen Inc.
Automation for the Win: Improving Bioassay Method Performance and Efficiency
Ahmed Hendawi and Sophia Arackal, Pfizer, Inc.
Session Speakers:
Lessons Learned for Potency Assays for Bispecific mAbs for Accelerated Programs
Marianne Hayes, Johnson & Johnson
Potency Assay Automation and How We Have Enhanced Cell Use and Production
Sheri Mahan-Hunter, Pfizer, Inc.
Potency Assurance for Cellular and Gene Therapy Products
Andrew P. Byrnes, CBER, FDA
In Vitro Functional Potency Assay Development and Qualification for a Late Stage AAV Based Gene Therapy Product
Debashree Basu, Ultragenyx Pharmaceutical Inc.
Session Speakers:
Adapting CMC Bioassay Strategies in Response to an Evolving ADC Pipeline
Patrick Hussman, AstraZeneca
Co-validation and Technology Transfer of an Automated Cell-Based Potency Method
Shelley Fang, GlaxoSmithKline
Apples and Oranges - Case Studies on Similarity, Comparability and Equivalence Regarding Potency Determination
Hermann Beck, F. Hoffmann-La Roche Ltd.
Regulatory Considerations for Bioassay Lifecycle Management
Leiyun Boone, CDER, FDA
Lunch will be available in Ballroom A-C. Grab lunch and head back to Ballroom D-G for the Vendor Showcase.
Join us during lunch to hear from the following vendor partners to learn what they are working on and how it can better serve your needs.
Participating Vendor Partners:
acCELLerate GmbH
Labcorp
Promega Corporation
Stegmann Systems
Svar Life Science AB
Welcome to Bioassays 2024, thank you for joining us!