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ISO/NP 25347

Biotechnology — Bioprocessing — General requirements for purification of extracellular vesicles

General information

10.20     Jul 3, 2024

ISO

ISO/TC 276

International Standard

Scope

Click or tap here to enter text.This document specifies general requirements for the establishment of fit for purpose purification process of extracellular vesicles (EVs) for therapeutic use. It includes selection of purification equipment and validation of the process.
This document provides requirements for purification equipment supplier of EVs as well as requirements for purification equipment user.
This document primarily, but not exclusively, covers EV purification from cell culture supernatants.

NOTE International, regional or national regulations or requirements can also apply to specific topics covered in this document.

Life cycle

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IN_DEVELOPMENT
ISO/NP 25347
10.20 New project ballot initiated
Jul 3, 2024

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