CMC Considerations for CAR T Cell Product Development

U.S. Food and Drug Administration
U.S. Food and Drug Administration
11.6 هزار بار بازدید - 3 سال پیش - FDA discusses the CMC requirements
FDA discusses the CMC requirements for CAR T Cell Product IND submissions, including early product development and product characterization for both autologous and allogenic products.
Presenter:
Kimberly Schultz, PhD, Gene Therapy Reviewer, Division of Cellular & Gene Therapies, Office of Tissues and Advanced Therapies (OTAT), CBER

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3 سال پیش در تاریخ 1400/01/26 منتشر شده است.
11,602 بـار بازدید شده
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