T/LNSI 010-2024 Human Amnion Mesenchymal Stem Cell Exosomes

Scope

Main technical content: 5. Technical requirements 5.1 Raw materials 5.1.1 They shall comply with the requirements of T/CSCB 0001-2022. 5.1.2 Standards for donor evaluation and screening, collection methods, transportation standards, and handover standards for donor cells shall be established to ensure the safety of donors and cells. 5.1.3 Donors shall be screened for HIV, HBV, HCV, HTLV, EBV, HCMV, and TP, and the results shall be recorded. 5.2 Preparation and purification methods 5.2.1 Human amniotic mesenchymal stem cells The key quality attributes of human amniotic mesenchymal stem cells shall comply with the provisions of T/LNSI 001-2023. 5.2.2 Culture supernatant of human amniotic mesenchymal stem cells To obtain high-quality exosomes, the optimal time for harvesting exosomes is defined as P2-P3 generation human amniotic mesenchymal stem cells, requiring a fusion rate of more than 95% in the cell supernatant. 5.2.3 Preparation and purification of exosomes They shall comply with the requirements of T/CSCB 0007-2022. 5.3 Key quality attributes 5.3.1 Morphology Observed by transmission electron microscopy, the morphology of exosomes is a double-membrane structure resembling a teacup. 5.3.2 Particle size The particle size of exosomes shall be less than 200 nm, with a peak particle size range of 60-120 nm. 5.3.3 Concentration The concentration of human amniotic mesenchymal stem cell exosomes used for anti-aging of skin and joints shall not be less than 3×1010 particles/ml. 5.3.4 Marker proteins Any two of the surface markers CD63, CD81, and CD9 on exosomes shall be positive. 5.3.5 Microorganisms They shall be negative for fungi, bacteria, mycoplasma, HIV, HBV, HCV, HTLV, EBV, HCMV, and TP. 5.3.6 Process control The process control of human amniotic mesenchymal stem cell preparation shall comply with the requirements of T/LNSI 001-2023. The process control of exosome separation shall comply with the requirements of

Development Information

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