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  • BSI
    20/30369896 DC BS ISO 23033. Biotechnology. Analytical methods. General guidelines for the characterization and testing of cellular therapeutic products
    Edition: 2020
    $44.66
    / user per year

Description of 20/30369896 DC 2020

This document defines terms and provides general requirements for the testing of cellular therapeutic products intended for human use.

This document also provides considerations for the characterization and testing of cellular therapeutic products, including approaches to select and design analytical methods that are fit for purpose, and considerations for setting specifications for the analytical methods.

Such considerations can be used to establish critical quality attributes (CQAs) for a cellular therapeutic product.

Aspects of this document are applicable to starting materials (including those for tissue engineered products) and intermediates of cellular therapeutic products.

This document excludes tissues used in transplantation.



Standard Number20/30369896 DC
TitleBS ISO 23033. Biotechnology. Analytical methods. General guidelines for the characterization and testing of cellular therapeutic products
StatusDefinitive
Publication Date2020-05-12
Identical National Standard OfISO/DIS 23033
DescriptorsBiotechnology, Immobilization (biotechnology), Testing, Quantitative analysis, Therapeutics
ICS07.080 Biology. Botany. Zoology
CommitteeBTI/1
PublisherBSI
Pages39

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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