Table 2.
Summary of day -X development studies
| Study | Parameter investigated | Acceptance criteria | Number of runs | Result (range) |
|---|---|---|---|---|
| Apheresis cryopreservation | filling Accuracy (%) | ±15% of target volume | 13 (42 bags filled) | 94.0% (85.2%–105.6%) |
| DMSO concentration (%) | for information only (target 5%) | 6 | 5.1% (4.5%–5.3%) | |
| post-thaw viability (%) | CD45: ≥70% CD3: for information only |
9 | CD45+: 80.9% (74.3%–87.4%) CD3+: 68.7% (50.9%–83.9%) |
|
| Drug product manufacturing | %CD3+ Cells | ≥80% | 1 | 99.6% |
| cell number | ≥1 × 1010 | 1 | 1.58 × 1010 | |
| transduction efficiency (%) | ≥10% | 1 | 39.4% | |
| vector copy number (copies/cell) | ≤5 copies/cell | 1 | 1.4 | |
| potency | antigen-specific killing detected | 1 | detected | |
| post-thaw viability (%) | ≥70% | 1 | 91.8% |