Association and enterprise standard for producing and monitoring of quality extracellular vesicles /exosomes derived from human mesenchymal stem cells

Abstract

This document is drafted in accordance with GB/T 1.1–2020 ''Standardization work guidelines Part 1: Structure and drafting rules for standardization documents'' to specify the identification methods, inspection rules, label, package,storage, transportation and waste disposal requirement of extracellular vesicles (EVs)/exosomes derived from human mesenchymal stem cells. Please note that certain contents of this document may refer to patents, and the issuing institution of this document does not assume responsibility for identifying patents. This document is led by Qingdao Haier Biotechnology Co. Ltd. in collaboration with other 80 biological companies, institutions and hospitals in China. This document is collectively contributed by 122 experts in stem cell field, and officially released by China Food and Drug Corporation Quality and Safety Promotion Association. Publication of this document in current version has been approved by the group leader Qingdao Haier Biotechnology Co, Ltd.

Keywords

• Association standard
• Enterprise Standard
• Human mesenchymal stem cells
• Extracellular vescicles(EVs)/exosomes
• China