T/CIQA 98-2024 Human dental pulp stem cell testing guidelines

Scope

Main technical content: 1. Key quality attributes 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 endotoxin 1.3.4 Endogenous and exogenous viral factors in cells 1.3.5 Tumorigenicity 1.3.6 Residuals 1.3.7 Biological efficacy 1.3.8 Immunological response (when applicable) 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 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 endotoxin 2.3.4 Endogenous and exogenous viral factors in cells 2.3.5 Tumorigenicity 2.4 Residuals 2.4.1 Antibiotic residuals 2.4.2 Bovine serum albumin residuals 2.4.3 Cytokine residuals 2.5 Biological efficacy 2.5.1 Osteogenic differentiation 2.5.2 Adipogenic differentiation 2.5.3 Chondrogenic differentiation 2.6 Immunological response (when applicable) 2.6.1 Inhibitory effect on T lymphocyte proliferation 2.6.2 Inhibitory effect on IFN-γ and TNF-α secretion in lymphocytes

Development Information

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