ISO/TS 20399-1:2018 PDF
Biotechnology — Ancillary materials present during the production of cellular therapeutic products — Part 1: General requirements
Open preview (PDF)Biotechnology — Ancillary materials present during the production of cellular therapeutic products — Part 1: General requirementsBiotechnology — Ancillary materials present during the production of cellular therapeutic products — Part 1: General requirements
- Document status:
- Withdrawn
- Format:
- Electronic (PDF)
- Number of pages:
- 10
- Publication date:
- December 4, 2018
- Edition:
- ISO TS 20399 edition 1 version 1
- ICS:
- 07.080
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.
Technical details
- Technical committee
- ISO/TC 276 - Biotechnology
- SKU
- ISO/TS 20399-1:2018
