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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. 

Session Chairs

Speaker Image for Adelheid Rohde
Speaker Image for Stephen Hartman
Speaker Image for Martin Nemec

Speakers

Speaker Image for Debashree Basu
Speaker Image for Andrew Byrnes
Speaker Image for Sheri Mahan-Hunter
Speaker Image for Marianne Hayes


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