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DANSK DS/ISO/TS 20399-1 PDF

DANSK DS/ISO/TS 20399-1 PDF

Name:
DANSK DS/ISO/TS 20399-1 PDF

Published Date:
12/12/2018

Status:
[ Withdrawn ]

Description:

Biotechnology – Ancillary materials present during the production of cellular therapeutic products – Part 1: General requirements

Publisher:
Dansk Standard

Document status:
Active
Format:
Electronic (PDF)
Delivery time:
10 minutes
Delivery time (for Russian version):
200 business days
SKU:
Choose Document Language:
$16.8
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W/D S/S BY DS/ISO 20399

This document specifies definitions and general requirements for ancillary materials (AMs) used in cell processing of cellular therapeutic products. This document 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 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.


Edition : 18
File Size : 1 file , 1.9 MB
Number of Pages : 20
Product Code(s) : DS-017, DS-017
Published : 12/12/2018

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