T/LNSI 001-2023 Human Amniotic Mesenchymal Stem Cells (hAMSCs)

Scope

Scope: This document specifies the technical requirements, testing methods, testing rules, usage instructions, labeling, packaging, storage, transportation, and waste disposal requirements for human amniotic mesenchymal stem cells. This document applies to the production and testing of human amniotic mesenchymal stem cells; Main technical content: 5.1 Raw materials and auxiliary materials 5.1.1 They shall comply with the requirements of T/CSCB 0001. 5.1.2 Standards for donor assessment and screening, collection methods, transportation standards, and handover standards 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 Separation and culture methods 5.2.1 Separation and extraction of human amniotic tissue: The tissue is minced into a paste and human amniotic mesenchymal stem cells are isolated using collagenase digestion. Primary culture of human amniotic mesenchymal stem cells is carried out. 5.2.2 Changing the culture medium for human amniotic mesenchymal stem cells: The medium is changed according to the growth status of the cells. 5.2.3 Passage of human amniotic mesenchymal stem cells: The passage operation should be performed at an appropriate density, in a timely and rapid manner. 5.2.4 Freezing and storage of human amniotic mesenchymal stem cells: After cooling, the cells are stored in liquid nitrogen. 5.2.5 Thawing and culturing of human amniotic mesenchymal stem cells: The frozen cells are rapidly thawed, centrifuged and washed, and then cultured. 5.2.5 Preparation of human amniotic mesenchymal stem cell preparations: The solution should be homogeneous, without flocculent sediment, and with a cell survival rate of ≥90%. 5.3 Key quality attributes 5.3.1 Cell morphology: The cells should be spindle-shaped and fusiform fibroblast-like when cultured on a substrate, with a uniform morphology. 5.3.2 Chromosom

Development Information

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