Standard

ISO/TS 20399-3:2018 en

Biotechnology - Ancillary materials present during the production of cellular therapeutic products - Part 3: Best practice guidance for ancillary material users

49,02 59,31 Incl BTW

About norm

Status Current
Number of pages 11
Committee Beleidscommissie Landbouw & Levensmiddelen
Published on 01-12-2018
Language English
ISO/TS 20399-3 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.

Details

ICS-code 07.080
English title Biotechnology - Ancillary materials present during the production of cellular therapeutic products - Part 3: Best practice guidance for ancillary material users

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