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 | – |
A release assay is defined as mandatory testing that must be carried out before shipping. A reference assay is defined as an important test for which the criteria cannot be standardized, but the results may delay the product release if any abnormality is identified