T/LNSI 004-2023 Human cytokine-induced killer cells

Scope

Scope: This document specifies the technical requirements, testing methods, testing rules, usage instructions, labels, packaging, storage, transportation, and waste disposal requirements for human cytokine-induced killer cells. This document applies to the quality control of human cytokine-induced killer cells obtained from the differentiation or transdifferentiation of human stem cells isolated from human tissues. Main technical contents: 5.1 Cell morphology: Cells cultured in vitro should be suspended and round in shape. 5.2 Chromosomal karyotype: The normal karyotype should be 46,XX or 46,XY. 5.3 Cell marker protein: The positive rate of CD3 and CD56 should be ≥25%. 5.4 Cell purity: The content of cells expressing the CD3 marker protein should be ≥90%. 5.5 Cell survival rate: The survival rate of freshly prepared non-frozen cells should be ≥90%; and that of thawed cells before use should be ≥70%. 5.6 Microorganisms: 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 cytokine-induced killer cells obtained from the differentiation or transdifferentiation of human stem cells isolated from human tissues should undergo STR testing and typing identification, with no cross-contamination between samples.

Development Information

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