T/CIQA 99-2024 Cellular factor-induced killer cell testing specifications
T/CIQA 99-2024 Cellular factor-induced killer cell testing specifications
Basic Information
Scope
Main technical content: 1. Key technical requirements 1.1 Cell identification 1.1.1 Cell morphology 1.1.2 Chromosome karyotype 1.1.3 Short tandem repeats (STR) 1.1.4 Phenotypic analysis 1.2 Cell survival rate and growth activity 1.2.1 Cell count and survival rate 1.2.2 Cell doubling time 1.2.3 Cell cycle 1.2.4 Cell growth curve 1.3 Safety 1.3.1 Sterility (bacteria, fungi) 1.3.2 Mycoplasma 1.3.3 Bacterial endotoxins 1.3.4 Endogenous and exogenous viral factors in cells 1.3.5 Tumorigenicity 1.4 Residues 1.4.1 Antibiotic residues 1.4.2 Bovine serum albumin residues 1.4.3 Cytokine residues 1.5 Biological efficacy 2. Testing methods 2.1 Cell identification 2.1.1 Cell morphology 2.1.2 Chromosome karyotype 2.1.3 Short tandem repeats (STR) 2.1.4 Phenotypic analysis 2.2 Cell survival rate and growth activity 2.2.1 Cell count and survival rate 2.2.2 Cell doubling time 2.2.3 Cell cycle 2.2.4 Cell growth curve 2.3 Safety 2.3.1 Sterility (bacteria, fungi) 2.3.2 Mycoplasma 2.3.3 Bacterial endotoxins 2.3.4 Endogenous and exogenous viral factors in cells 2.3.5 Tumorigenicity 2.4 Residues 2.4.1 Antibiotic residues 2.4.2 Bovine serum albumin residues 2.4.3 Cytokine residues