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93550

Session I: Nuts and Bolts of Bioassays

Date
April 16, 2024
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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.