Table 2 Quality tested items
Status | Test item | Method | Criteria |
|---|---|---|---|
Release assay | Morphology | Microscopy | ES cell-like |
HLA | PCR-SBT | Match with origin | |
STR | PCR and capillary electrophoresis | Match with origin | |
Bacteriology | BacT/ALERT | Negative | |
Viral testing | PCR | Negative | |
Endotoxin | Kinetic turbidimetric | ≦ 5 EU/mL | |
Mycoplasma | PCR | Negative | |
Reference assay | Pluripotent marker expression | Flow cytometry | – |
Microarray | – | ||
SNV/Indel | WGS/WES | – | |
CNV | WGS/SNP array | – | |
Analysis of genetic variation | WGS | ||
Karyotype | Conventional Giemsa staining | – | |
G-banding | – | ||
Residual vector | PCR (Taqman qPCR) | – | |
Cell number and viability immediately after thawing | Cell count | – | |
Average of doubling time among 3 passages of subculture | Cell count | – | |
Cell number and viability after 6–7 days culture of thawed cells | Cell count | – |