Biotechnology. Ancillary materials present during the production of cellular therapeutic products - Best practice guidance for ancillary material suppliers Ingestion-build-146508 Secure electronic database

Secure electronic database

using input from the relevant system standards referred to in this International Standard and specified in Annex A

Conformity assessors dealing with the technical aspects of bearings

IEC 60068-2-38

according to EN 13384-1:2015

Biotechnology. Ancillary materials present during the production of cellular therapeutic products - Best practice guidance for ancillary material suppliers Ingestion-build-146508 Secure electronic databaseWhat 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