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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
Tracks
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