Table 2.
Specifications and results from GMP batch analysis (n = 13)
| Parameter | Test method | Specification | Mean | Deviations from specification | |
|---|---|---|---|---|---|
| Absolute | Percentage | ||||
| ABCB5+ cell content | Flow cytometry | ≥ 90% | 96.4% | 0 | 0% |
| Mycoplasma | Nucleic acid test-based assay (2.6.7 Ph. Eur.) | not detectable (< 10 CFU/ml) | < 10 CFU/ml | 0 | 0% |
| Endotoxin level | LAL-Test (2.6.14 Ph. Eur.) | ≤ 2 EU/ml | ≤ 2 EU/ml | 0 | 0% |
| Cell vitality | Flow cytometry (2.7.29 Ph. Eur.) | ≥ 90% | 97.5% | 1 | 7.7% |
| Cell viability | Flow cytometry (2.7.29 Ph. Eur.) | ≥ 90% | 99.2% | 0 | 0% |
| Bead residues | Flow cytometry | ≤ 0.5% | 0.04% | 0 | 0% |
| Microbiological control (n = 12)a) | BacT/ALERT® System (adapted to 2.6.27 Ph. Eur.) | no growth | n.a. | 0 | 0% |
| p63+ cell content | Immunofluorescence | ≥ 20% | 76,7% | 0 | 0% |
| PAX6+ cell content (n = 8)b) | Immunofluorescence | ≥ 50% | 71.3% | 0 | 0% |
Ph. Eur. European Pharmacopeia, LAL Limulus amebocyte lysate, n.a. not applicable
aOne batch could not be evaluated due to sample size error and was therefore not released
bFive batches could not be evaluated due to staining problems and were therefore not released