T/SZBMPA 004-2026 General Requirements for Purification Instruments of Human Mesenchymal Stromal Cell-Derived Extracellular Vesicles at Small-and Pilot-Scale
T/SZBMPA 004-2026 General Requirements for Purification Instruments of Human Mesenchymal Stromal Cell-Derived Extracellular Vesicles at Small-and Pilot-Scale
Basic Information
Scope
This document will define the general requirements for pilot-scale purification instruments of extracellular vesicles derived from human mesenchymal stem cells. The aim is to improve the quality of exosome research, promote the standardization of the industry of extracellular vesicles derived from human mesenchymal stem cells, and accelerate the application of extracellular vesicles derived from human mesenchymal stem cells in drug research and development and regenerative medicine. When formulating extracellular vesicle standards, attention will also be paid to aligning with international guidelines (Minimal information for studies of extracellular vesicles (MISEV2023): From basic to advanced approaches), with the aim of formulating more comprehensive, standardized, and practical group standards.