From: GMP-conformant on-site manufacturing of a CD133+ stem cell product for cardiovascular regeneration
Validation no. | No. of viable CD133+cells (×106) in 5 ml | Cell viability [%] | Depletion of non-target cells [−log CP] |
---|---|---|---|
1 | 1.0 | 97.92 | 3.86 |
2 | 0.28 | 77.17 | 2.82 |
3 | 0.57 | 71.42 | 2.60 |
4 | 0.19 | 87.13 | 3.46 |
5 | 0.12 | 77.66 | 3.49 |
6 | 0.97 | 87.53 | 3.17 |
Mean | 0.52 | 83.14 | 3.23 |
SEM | 0.16 | 3.90 | 0.19 |
Acceptance range | 0.05–5 × 106 | ≥70% | ≥2.5 log |