Ehdotuksen tiedot

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.