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Table 8 GMP process validation

From: Bone marrow-derived cells for cardiovascular cell therapy: an optimized GMP method based on low-density gradient improves cell purity and function

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
  1. EU: Endotoxin Units; WBC: White Blood Cells; PLT: Platelets; CFC: Colony Forming Cells; CFU-F: Colony Forming Units-Fibroblasts; FIO: For information only.
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