Table 4.
Analysis of product stability
| Parameter | Validation run | TCF after enrichment | 48 h | 54 h | 72 h | |||
|---|---|---|---|---|---|---|---|---|
| value | recovery | value | recovery | value | recovery | |||
| WBC | 1. run | 1.43x107 | 9.60x106 | 67.00% | 7.80x106 | 54.50% | 7.60x106 | 53.10% |
| 2. run | 5.00x106 | 4.40x106 | 88.00% | 4.20x106 | 84.00% | 4.00x106 | 80.00% | |
| 3. run | 1.25x107 | 8.60x106 | 69.00% | 7.30x106 | 58.60% | 6.50x106 | 51.70% | |
| viable WBC | 1. run | 1.01x107 | 8.00x106 | 79.50% | 7.20x106 | 71.60% | 6.20x106 | 61.70% |
| 2. run | 3.40x106 | 3.20x106 | 94.10% | 3.80x106 | >100% | 3.60x106 | >100% | |
| 3. run | 6.00x106 | 5.20x106 | 85.70% | 4.30x106 | 71.40% | 3.90x106 | 64.30% | |
| viable T cells | 1. run | 1.74x106 | 1.42x106 | 81.61 | 1.32x106 | 75.86% | 1.22x106 | 70.11% |
| 2. run | 2.97x106 | 2.17x105 | 73.06% | 1.97x105 | 66.33% | 2.49x105 | 83.84% | |
| 3. run | 1.83x106 | 2.12x106 | >100% | 1.85x106 | >100% | 2.09x106 | >100% | |
Stability of the cells from the T-cell fraction (TCF) was analysed after 48 h, 54 h and 72 h post-leukapheresis with respect to total numbers of WBCs [x106], viable WBCs [x106] viable T cells (CD3+CD56− T cells) [x106], and recovery [%]. Detection of total cell numbers and viability was performed by light microscopy using trypan blue dye.