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  • BSI
    PD ISO/TS 20399-3:2018 Biotechnology. Ancillary materials present during the production of cellular therapeutic products - Best practice guidance for ancillary material users
    Edition: 2018
    $316.70
    / user per year

Description of PD ISO/TS 20399-3:2018 2018

This document provides guidance for ancillary material (AM) users. It 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 focuses primarily on ancillary materials (AMs) of biological (human and animal) origin and their potential impurities and contaminants.

NOTE 1 The decision chart in Figure 1 illustrates the rationale underlying the scope of this document.

However, diverse biological sources, including plants, insects and marine organisms, can also be used in the development of a cellular therapeutic product. Therefore the fundamental principles of risk management also apply for these sources of AMs.

This document does not cover the selection, assessment or control of starting materials and excipients. However, it is anticipated that these are still covered by general risk management procedures.

This document is applicable for users at all stages of clinical development and supply; however maximum benefits can be gained by the implementation of the recommendations in the early stages of development.

NOTE 2 International, regional or national regulations or requirements can also apply to specific topics covered in this document.

Figure 1Decision chart

image



Standard NumberPD ISO/TS 20399-3:2018
TitleBiotechnology. Ancillary materials present during the production of cellular therapeutic products - Best practice guidance for ancillary material users
StatusWithdrawn
Publication Date2018-12-07
Withdrawn Date2023-01-16
Replaced ByBS ISO 20399:2022
Identical National Standard OfISO/TS 20399-3:2018
DescriptorsProducts, Cells (biology), Ancillary, Production, Biotechnology
ICS07.080 Biology. Botany. Zoology
CommitteeBTI/1
ISBN978 0 580 94263 1
PublisherBSI
Pages20

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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