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DS/ISO 23033:2021

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

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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Danish Standards [ds]

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