Draft
International Standard
ISO/DIS 25347
Biotechnology — Bioprocessing — General requirements for the purification of extracellular vesicles
Reference number
ISO/DIS 25347
Edition 1
© ISO 2026
Draft International Standard
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ISO/DIS 25347

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CHF 67
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Abstract

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.

General information

  • Status
     : Under development
    Stage
    : Close of voting [40.60]
  • Edition
     : 1
    Number of pages
     : 11
  • Technical Committee :
    ISO/TC 276
    ICS :
    07.080 
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Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goals

3
Good Health and Well-being
4
Quality Education
8
Decent Work and Economic Growth
9
Industry, Innovation and Infrastructure
12
Responsible Consumption and Production

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