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Qualification of Raw Materials Used in the Manufacturing ...

Qualification of Raw Materials used in the Manufacturing of Cellular TherapiesJim Richardson, Science and Standards Liaison, Global BiologicsLast Update: October 2019 Jim RichardsonCourse ID: BIO-QUAL-01 Challenges in raw material Qualification for cell therapy developers Background on raw Materials , definitions and regulatory expectations Qualification programs for raw Materials USP ancillary material standards Opportunities for standardization and future plansOutline2 2018 USP3 2019 USP Non-cGMP or research grade Materials used for production Materials available from single or limited number of suppliers Lot to lot variability in material quality/function Vendor testing insufficient to assure functionality Cell therapy products are generally not amenable to extensive purification, filtration.

Raw materials may or may not remain in the final therapeutic product as active substances or as impurities Ancillary materials are a subset of raw materials. –Ancillary products may exert an effect on a therapeutic substance (e.g. a cytokine may activate a population of cells), but they are not intended to be in final formulation

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