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ISO 23033:2021

Biotechnology - Analytical methods - General requirements and considerations for the testing and characterization of cellular therapeutic products
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ISO 23033:2021

Biotechnology - Analytical methods - General requirements and considerations for the testing and characterization of cellular therapeutic products

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

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

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

This document is applicable to cellular starting materials (including those for tissue engineered products) and intermediates of cellular therapeutic products.

This document is not applicable to tissues used in transplantation.

SDO ISO: International Organization for Standardization
Document Number ISO 23033
Publication Date Not Available
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 276
Publish Date Document Id Type View
Not Available ISO 23033:2021 Revision