Table 4.
Translation of production procedures from CB to BM from three patients. QC testing showing the compliance to thresholds established during step 1 validation procedure using CB
| Test | Method | Specification | Result | (Mean ± S.D.) | ||
|---|---|---|---|---|---|---|
| Patient #1 | Patient #2 | Patient #3 | ||||
| Purity | Flow cytometry (% of CD133+) | ≥50% | 51.31% | 90.87% | 78.38% | 73.52 ± 20.22 |
| Viability after isolation | Flow cytometry (propidium iodide staining) | ≥70% | 98.37% | 99.93% | 98.02% | 98.77 ± 1.02 |
| Number of nucleated cells recovered from CliniMACS | Automated/manual cell counting | ≥106 | 4.46 × 106 | 9.31 × 106 | 3.32 × 106 | 5.70 × 106± 3.18 × 106 |
| Sterility | Sterility test (European Pharmacopeia) | Negative | Negative | Negative | Negative | - |
| Mycoplasma | Cultural test (European Pharmacopeia) | Negative | Negative | Negative | Negative | - |
| Endotoxin | Limulus amebocyte lysate test (European Pharmacopeia) | <0.5 EU/ml | <0.24 EU/ml | <0.24 EU/ml | <0.24 EU/ml | <0.24 EU/ml |