Table 8 GMP process validation
Parameter | Specification | Results – Lot Number: | ||
|---|---|---|---|---|
002.12 | 004.12 | 005.12 | ||
Visual control: appearance | Limpid; absence of micro aggregates, colorless to slightly hematic | Limpid, absence of micro aggregates, colorless | Limpid, absence of micro aggregates, colorless | Limpid, absence of micro aggregates, colorless |
Integrity of primary container | Intact | Intact | Intact | Intact |
Sterility | No growth | No growth | No growth | No growth |
Bacterial endotoxins (EU/ml) | < 5.00 | < 5.00 | < 5.00 | < 5.00 |
Cell concentration (WBC/ml) | FIO | 1.20 × 106 | 2.40 × 106 | 1.25 × 106 |
Lymphocytes (%) | ≥ 30 | 71 | 57 | 61 |
Monocytes (%) | ≥ 8 | 14 | 16 | 14 |
Granulocytes (%) | ≤ 55 | 15 | 27 | 25 |
Platelet concentration (PLT/ml) | FIO | 6.30 × 106 | 1.50 × 107 | 7.50 × 106 |
PLT/WBC | ≤ 10 | 5 | 6 | 6 |
Hematocrit (%) | ≤ 3 | 0.1 | 0.1 | 0.05 |
CD45+/CD34+ (%) | FIO | 2.94 | 8.41 | 8.95 |
CD45+/CD133+ (%) | FIO | 1.42 | 3.8 | 4.25 |
Cell viability (%) | ≥ 70 | 74 | 84 | 99 |
CFC (colonies/106 cells) | FIO | 2 450 | 9 850 | 11 550 |
CFU-F (colonies/106 cells) | FIO | 44 | 55 | 36 |
Invasion (invasion index) | FIO | 35 | 59 | 47 |