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ISO 23033:2021

Biotechnology — Analytical methods — General requirements and considerations for the testing and characterization of cellular therapeutic products
27. 8. 2021.

Опште информације

90.92     9. 6. 2026.

ISO

ISO/TC 276/SC 1

Međunarodni standard

07.080  

engleski   francuski  

Kupovina

Objavljen

Jezik na kome želite da primite dokument.

Apstrakt

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.

Životni ciklus

TRENUTNO

OBJAVLJEN
ISO 23033:2021
90.92 Odluka o izmeni ili reviziji standarda
9. 6. 2026.

REVIDIRAN OD

PROJEKAT
ISO/AWI 23033-1