T/LNSI 002-2023 Amniotic Membrane Epithelial Stem Cells (AMSCs)

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 epithelial stem cells. This document applies to the production and testing of human amniotic epithelial 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 Supplier assessment and screening standards, 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 Separation and culture methods 5.2.1 Separate and extract human amniotic tissue samples into slices, and isolate human amniotic epithelial stem cells using trypsin digestion. Conduct primary culture of human amniotic epithelial stem cells. 5.2.2 Change the culture medium for human amniotic epithelial stem cells according to their growth status. 5.2.3 Passage of human amniotic epithelial stem cells should be carried out with appropriate density, timely and quickly. 5.2.4 Freeze-preserve human amniotic epithelial stem cells by cooling and storing them in liquid nitrogen after cooling. 5.2.5 Thaw and culture human amniotic epithelial stem cells by removing the freezing tube, rapid thawing, and centrifugal washing. 5.2.6 Human amniotic epithelial stem cell solution should be a homogeneous state without flocculent sediment, and the cell survival rate should be ≥90%. 5.3 Key quality attributes 5.3.1 Cell morphology: The cells should be irregular polygonal in shape and grow in a cobblestone pattern with uniform morphology during adherence and culture. 5.3.2 Chromosomal karyotype: The normal karyotype should be 46,XX or 46,XY. 5.3.3 Cell survival rate: The survival rate of unfrozen cells should be ≥90%, and the survival

Development Information

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