Abstract
Click or tap here to enter text.This document specifies general requirements for the establishment of fit for purpose purification process of extracellular vesicles (EVs) for research and development. It includes selection of purification equipment and validation of the process. This document provides requirements for purification equipment supplier of EVs as well as requirements for purification equipment user. This document primarily, but not exclusively, covers EV purification from cell culture supernatants. NOTE International, regional or national regulations or requirements can also apply to specific topics covered in this document.
General information
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Status: Under developmentStage: Working draft (WD) study initiated [20.20]
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Edition: 1
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Technical Committee :ISO/TC 276
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