Ancillary materials (AMs), also called raw materials in Europe, are components, reagents, and materials used in the manufacturing of cell, gene, and tissue-engineered (CGT) therapies but are not intended to be present in the final product formulation. AMs include, but are not limited to, cell culture reagents and additives (e.g. transfection reagents and antibiotics), cryopreservation agents, and disposables such as plasticware and bioprocessing bags. While ancillary materials are not intended to be detectable in the final therapeutic, their presence in the manufacturing process may affect the final drug's safety, efficacy, stability and consistency. Therefore, it is critical for CGT therapy manufacturers to carefully define the selection criteria and subsequent qualification program for AMs.
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