Parameter | Specification | Result | Deviations | |
---|---|---|---|---|
absolute | % | |||
ABCB5+ cell content | ≥ 90% | 97.72 ± 1.88% | 1a | 1.5a |
Mycoplasma | Not detectable (< 10 CFU/ml) | Not detectable in 65/66 batches | 1 | 1.5 |
Endotoxin level | ≤ 2 EU/ml | ≤ 2 EU/ml in 66/66 batches | 0 | 0 |
Live cell count | n.a.b | 275.33 × 106 | n.a.b | n.a.b |
Deviation of live cell count from expected valuec | ≤ 30% | ≤ 30% in 46/49 batchesd | 3 | 6%d |
Cell vitalitye | ≥ 90% | 98.60 ± 0.62% | 0 | 0 |
Cell viabilityf | ≥ 90% | 99.45 ± 0.64% | 0 | 0 |
CD90+ cell content | ≥ 90% | 99.45 ± 0.50% | 0 | 0 |
Bead residues | ≤ 0.5% | 0.04 ± 0.05% | 0 | 0 |
Microbiological control | No growth | No growth in 66/66 batches | 0 | 0 |
IL-1RA secretion | > 125 pg/ml and ratiostim/unstim > 1 | > 125 pg/ml and ratiostim/unstim > 1 in 66/66 batches | 0 | 0 |
VEGF secretion | > 46.9 pg/ml | > 46.9 pg/ml in 66/66 batches | 0 | 0 |
Angiogenic differentiation | Capillary structures in one or both seeded cell concentrations | positive in 63/66 batches | 3 | 4.5% |