ISO/DIS 25347

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

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. 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.