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ISO/DIS 25347

Biotechnology — Bioprocessing — General requirements for the purification of extracellular vesicles

Draft Public enquiry
Comment end date 2026-05-11
Export comments Read draft and comment

Project stage codes

1. CD study/ballot initiated
2. Viešoji apklausa
From 2026-03-16 till 2026-05-11
3. Closure of enquiry

Organisation

ISO Tarptautinė standartizacijos organizacija

ICS

07.080 - Biology. Botany. Zoology

Technical Committee

TK 87 Biotechnology

ForeignTC'S

ISO/TC 276

Number of comments

0

Comment start date

2026-03-16

Scope

This document specifies general requirements for the establishment of a fit for purpose purification process for extracellular vesicles (EVs) specifically for research and development. It includes the selection of the purification method, equipment and 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. It is also applicable to EV purification from body fluid. NOTE International, regional or national regulations or requirements can also apply to specific topics covered in this document.