ISO/TS 20399-1:2018

Name: ISO/TS 20399-1:2018
Brand: ISO
SKU: ISO/TS 20399-1:2018
Price: 76.23 EUR
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Biotechnology — Ancillary materials present during the production of cellular therapeutic products — Part 1: General requirements

Publication date: Dec 4, 2018

95.99 Withdrawal of Standard Dec 1, 2022

General information

Current stage: 95.99 Withdrawal of Standard Dec 1, 2022

Originator: ISO

Owner: ISO/TC 276 Biotechnology

Type: Technical Specification

ICS: 07.080 Biology. Botany. Zoology

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Status: Withdrawn

PDF - €76.23

Languages: 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WITHDRAWN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