Bioassays 2024

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!