T/LNSI 009-2024 Active

Main technical content: 5. Technical requirements 5.1 The cell morphology in vitro culture is in a suspended state. After activation, the cells increase in size or become irregular in shape, with one or more pseudopod-like protrusions visible around them. 5.2 The chromosomal karyotype should be normal, with a karyotype of 46,XX or 46,XY. 5.3 The cell marker protein CD3 is negative, and the CD56 positivity rate should be ≥70%. 5.4 The cell purity should be ≥80% of cells expressing the CD56 marker protein. 5.5 The cell survival rate should be ≥90% for freshly prepared non-frozen cells and ≥70% for thawed frozen cells before use. 5.6 Microorganisms such as fungi, bacteria, mycoplasma, chlamydia, HIV, HBV, HCV, HTLV, EBV, HCMV, and TP should all be negative. 5.7 Endotoxin: The endotoxin level should be ≤0.5 EU/mL. 5.8 Cell STR identification: Human natural killer cells isolated from human tissue or obtained through stem cell differentiation or transdifferentiation should undergo STR testing and typing identification to ensure no cross-contamination between samples.