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ISO 23033:2021

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

Publication date:   Aug 27, 2021

General information

90.92   Standard to be revised   Jun 9, 2026

ISO

ISO/TC 276/SC 1

International Standard

07.080   Biology. Botany. Zoology

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Scope

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.

Life cycle

NOW

PUBLISHED
ISO 23033:2021
90.92 Standard to be revised
Jun 9, 2026

REVISED BY

IN_DEVELOPMENT
ISO/AWI 23033-1




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