Table 6 Release criteria for the finished product and quality controls performed on the target fraction during the validation process
Parameter | Validation run | Finished product specification | |||
|---|---|---|---|---|---|
#01 [KD1] | #02 [KD2] | #03 [LD1] | #04 [LD2] | ||
TNC viability | nd | 97.9% | 98.3% | 98.9% | ≥ 90% |
Purity | 98.3% | 97.6% | 89.2% | 97.9% | > 80% |
CD127− Treg cells (%) | 94.7% | 96.5% | 88.9% | 97.6% | > 80% |
FoxP3+Treg cells (%) | 91.1% | 96.5% | 84.6% | 88.8% | > 80% |
CD127−FoxP3+ (%) | 79.2% | 96.1% | 84.4% | 88.6% | > 80% |
CD45+CD19+ (%) | 0.0% | 0.0% | 0.0% | 0.0% | < 2% |
CD45+CD56+ (%) | 0.1% | 0.0% | 0.0% | 0.0% | < 2% |
CD45+CD8+ (%) | 0.5% | 1.5% | 0.7% | 0.5% | < 2% |
Residual beads count§ | na | 405 | 397 | 156 | < 1000 |
Microbial growth (sterility)# | Sterile (4/4 batches) | Sterile (no growth) | |||
Mycoplasma | No growth | No growth | |||
Endotoxin | < 0.3 EU/mL (4/4 batches) | ≤ 0.3 EU/mL | |||