Strategic human raw material selection for cell therapy manufacturing

The use of human-derived raw materials plays a critical role in the success of cellular therapies, such as CAR-T cell manufacturing. In this article, we focus specifically on human serum albumin and male AB serum, exploring their evaluation and integration into production processes. Drawing on eight years of clinical-grade ARI-0001 manufacturing experience, we examine regulatory requirements, quality considerations, and practical implementation strategies.

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