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93548

Session II: Lifecycle Management for Bioassays

Date
April 16, 2024
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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













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