Reference number
ISO/TS 20399-1:2018
© ISO 2025
Technical Specification
ISO/TS 20399-1:2018
Biotechnology — Ancillary materials present during the production of cellular therapeutic products — Part 1: General requirements
Edition 1
2018-11
Withdrawn
Withdrawn (Edition 1, 2018)

Abstract

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.

General information

  • Status
     : Withdrawn
    Publication date
     : 2018-11
    Stage
    : Withdrawal of International Standard [95.99]
  • Edition
     : 1
    Number of pages
     : 10
  • Technical Committee :
    ISO/TC 276
    ICS :
    07.080 
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goals

3
Good Health and Well-being
9
Industry, Innovation and Infrastructure

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