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Evaluation consideration for risk control strategies of crucial raw materials used in cell therapy products
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Abstract:
Immunotherapy products, represented by chimeric antigen receptor-modified T lymphocytes (CAR-T cells), have achieved significant progress in hematologic malignancies such as leukemia. The raw materials used in the production of cell therapy products are diverse and complex, with gene modification vectors and other raw materials that endow cells with specific functionalities or influence their qualities usually classified as crucial raw materials. These crucial raw materials often have significant impacts on the quality attributes and in vivo efficacy of cell therapy products, making them important concerns in the evaluation of cell therapy products. This article summarizes several crucial raw materials that are commonly used in cell therapy products (including lentiviral vectors and γ-retroviral vectors, CRISPR/Cas gene editing system, transposon system, immunomagnetic separation beads, and feeder layer cells) and proposes the current evaluation considerations and risk control strategies with the aim of advancing the clinical transformation and application of such products.
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