PD ISO/TS 20399-2:2018 Biotechnology. Ancillary materials present during the production of cellular therapeutic products. Best practice guidance for ancillary material suppliers

PD ISO/TS 20399-2:2018

Biotechnology. Ancillary materials present during the production of cellular therapeutic products. Best practice guidance for ancillary material suppliers

Status : Current, Project Underway   Published : December 2018

Format
PDF

Format
HARDCOPY



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 AMs described in this document include those of biological origin [e.g. sera, media (including media additives), growth factors, and monoclonal antibodies] and chemical origin. This document does not address dimethyl sulfoxide (DMSO) for cryopreservation, beads, scaffolds, feeder cells, apparatus and instruments, or additives used post bioprocessing.

This document does not cover the selection, assessment or control of starting materials and excipients.

NOTE International, regional or national regulations or requirements can also apply to specific topics covered in this document.




Standard NumberPD ISO/TS 20399-2:2018
TitleBiotechnology. Ancillary materials present during the production of cellular therapeutic products. Best practice guidance for ancillary material suppliers
StatusCurrent, Project Underway
Publication Date07 December 2018
Normative References(Required to achieve compliance to this standard)ISO/TS 20399-1
Informative References(Provided for Information)PAS 84:2012, PAS 157:2015, ISO 13485, ICH Q6B, ICH Q7, FDA 1989, EP 5.2.12, ICH Q5E, ICH Q9, EP 2262, ISO 9001, ICH Q10
International RelationshipsISO/TS 20399-2:2018
DescriptorsProduction, Ancillary, Products, Cells (biology), Biotechnology
ICS07.080
Title in FrenchBiotechnologie. Matériaux auxiliaires présents lors de la production de produits thérapeutiques cellulaires Lignes directrices de bonne pratique pour les fournisseurs de matériaux auxiliaires
CommitteeBTI/1
ISBN978 0 580 94262 4
PublisherBSI
FormatA4
DeliveryYes
Pages20
File Size614 KB
Price£130.00


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