Biotechnology. Ancillary materials present during the production of cellular therapeutic products - Best practice guidance for ancillary material users Ingestion-build-98192 Who is BS EN 15436-1

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Annex B (informative) Example of a report — Sampling from groundwaters

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Biotechnology. Ancillary materials present during the production of cellular therapeutic products - Best practice guidance for ancillary material users Ingestion-build-98192 Who is BS EN 15436-1What 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 form part of the final product. It does not apply to products without cells. This document focuses primarily on ancillary materials (AMs) of biological (human and animal) origin and their potential impurities and contaminants. NOTE 1 The decision chart in