This paper provides joint industry recommendations by Subject Matter Experts in the development and manufacturing of cell-based therapy products to demonstrate comparability for some of the common process changes implemented by manufacturers that may occur during the clinical development lifecycle. Changes with the potential for a significant impact to cell-based therapy products were assessed for comparability recommendations, with the focus on the pre-pivotal and pivotal phases. The resulting recommendations are intended to help manufacturers with the design and approach for comparability studies to streamline study design and execution, as well as organization of data for accelerated regulatory agency approvals.
Regulatory Strategy
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