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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.