Biotechnology. Ancillary materials present during the production of cellular therapeutic products - Best practice guidance for ancillary material suppliers Ingestion-build-100998 BS EN ISO 8835-3:2009 +

BS EN ISO 8835-3:2009 + Amendment 1:2010

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Abel closed-cup method

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ISBN 0 580 432661

Biotechnology. Ancillary materials present during the production of cellular therapeutic products - Best practice guidance for ancillary material suppliers Ingestion-build-100998 BS EN ISO 8835-3:2009 +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, biosafety, performance, as well as the accompanying documentation. This document is applicable to cellular therapeutic products, including gene therapy products whereby cells form part of the final product. It does not apply to products without cells. The