Draft
International StandardISO/DIS 25347
Biotechnology — Bioprocessing — General requirements for the purification of extracellular vesicles
Reference number
ISO/DIS 25347
ISO/DIS 25347
Edition 1
© ISO 2026
Projet Norme internationale
ISO/DIS 25347
89980
Projet de Norme internationale au stade enquête auprès des membres de l’ISO.
ISO/DIS 25347
ISO/DIS 25347
89980
CHF
67
Résumé
This document specifies general requirements for the establishment of a fit for purpose purification process for extracellular vesicles (EVs) specifically for research and development. This document includes requirements for selection of purification methods and equipment, and for validation of the purification process.
This document provides requirements for purification equipment suppliers of EVs as well as requirements for purification equipment users.
This document is applicable to EV purification from cell culture supernatants. This document is also applicable to EV purification from body fluid.
Informations générales
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État actuel: ProjetStade: Clôture du vote [40.60]
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Edition: 1
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Comité technique :ISO/TC 276ICS :07.080
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