T/CSCB 0007-2022 General Requirements for the Preparation of Extracellular Vesicles Derived from Human Stem Cells
T/CSCB 0007-2022 Human-derived stem cell-derived extracellular vesicle preparation generic requirements
Basic Information
Scope
Scope: This document specifies the general requirements for the preparation of extracellular vesicles from human stem cells, process requirements, packaging and labeling requirements, and storage requirements, and describes the corresponding verification methods. This document is applicable to the research and production of extracellular vesicles from human stem cells, such as human embryonic stem cells, human mesenchymal stem cells, and human induced pluripotent stem cells. Main technical content: Foreword 1. Scope 2. Normative referenced documents 3. Terms and definitions 4. Abbreviations 5. General requirements 6. Process requirements 7. Packaging and labeling requirements 8. Storage requirements 9. Information and data management Appendix A (informative) Main parameters of Grade A clean areas Appendix B (informative) Example of preparation procedures for extracellular vesicles from human stem cells References