ISO/TS 20399-1:2018 PDF

ISO/TS 20399-1:2018 PDF

Name:
ISO/TS 20399-1:2018 PDF

Published Date:
10/31/2018

Status:
[ Withdrawn ]

Description:

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

Publisher:
International Organization for Standardization (Technical Standard)

Document status:
Active

Format:
Electronic (PDF)

Delivery time:
10 minutes

Delivery time (for Russian version):
200 business days

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Choose Document Language:
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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.


File Size : 1 file , 1.3 MB
Note : This product is unavailable in Russia, Ukraine, Belarus
Number of Pages : 18
Published : 10/31/2018
Same As : ISO/TS 20399-1:2018

History

ISO/TS 20399-3:2018
Published Date: 10/31/2018
Biotechnology - Ancillary materials present during the production of cellular therapeutic products - Part 3: Best practice guidance for ancillary material users
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ISO/TS 20399-1:2018
Published Date: 10/31/2018
Biotechnology - Ancillary materials present during the production of cellular therapeutic products - Part 1: General requirements
$21.9
ISO/TS 20399-2:2018
Published Date: 10/31/2018
Biotechnology - Ancillary materials present during the production of cellular therapeutic products - Part 2: Best practice guidance for ancillary material suppliers
$21.9

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