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What is this standard about? This document provides guidance for ancillary material (AM) suppliers to maintain a high level of lot-to-lot consistency in the aspects of identity, purity, stability, bi…
What is this standard about? This document provides guidance for ancillary material (AM) users. It is applicable to cellular therapeutic products, including those gene therapy products whereby cells…
1 Scope This document specifies definitions and general requirements for ancillary materials (AMs) used in cell processing of cellular therapeutic products . This document is applicable to cellular t…