SS-ISO-23033 › Biotechnology Analytical methods General guidelines for the characterization and testing of cellular therapeutic products (ISO 23033:2021, IDT)
SS-ISO-23033
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2022 EDITION
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CURRENT
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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.
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Designation Name
SS-ISO 23033:2022
Revision Level
2022 EDITION
Status
Current
Publication Date
Aug. 24, 2022
Language(s)
English
Page Count
44
International Equivalent
ISO 23033:2021(IDT)