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ISO DIS 23033

Biotechnology — Analytical methods — General guidelines for the characterization and testing of cellular therapeutic products

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Organization: ISO
Publication Date: 8 May 2020
Status: active
Page Count: 37
ICS Code (Biology. Botany. Zoology): 07.080
scope:

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.

Document History

ISO DIS 23033
May 8, 2020
Biotechnology — Analytical methods — General guidelines for the characterization and testing of cellular therapeutic products
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...

References

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