CMC Considerations for CAR T Cell Product Development

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
Learn more at: www.fda.gov/drugs/news-events...
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