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ISO/TS 20399-1:2018

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

Dec 4, 2018
95.99 Withdrawal of Standard   Dec 1, 2022

General information

95.99     Dec 1, 2022

ISO

ISO/TC 276

Technical Specification

07.080  

English  

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Scope

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.

Life cycle

NOW

WITHDRAWN
ISO/TS 20399-1:2018
95.99 Withdrawal of Standard
Dec 1, 2022

REVISED BY

PUBLISHED
ISO 20399:2022