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2022 ISPE Annual Meeting & Expo

SES108e - Regulatory Considerations and Challenges in Development of Cell Therapy Products – CMC Perspective

Oct 31, 2022 1:45pm ‐ Oct 31, 2022 3:15pm


This presentation will cover pertinent Chemistry, Manufacturing, and Controls (CMC) regulatory considerations in the development of cell therapy products. This will include a discussion on typical regulatory challenges encountered in cell therapy product development and clinical study phase-dependent CMC considerations.


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