Research Article
Full GMP-Compliant Validation of Bone Marrow-Derived Human CD133+ Cells as Advanced Therapy Medicinal Product for Refractory Ischemic Cardiomyopathy
Table 3
Summary of release data in 8 ATMP-CD133 batches.
| Release test | Results | Acceptance criteria | Mean | Standard deviation | Median | Range |
| Purity (%) | 88.86 | ±6.21 | 90.60 | 81.40–96.20 | ≥50% | Viability (%) | 99.13 | ±1.47 | 99.87 | 96.03–99.97 | ≥70% | Cellularity (×106) | 10.37 | ±9.08 | 9.69 | 2.85–30.84 | ≥1.0 × 106 | Sterility | Sterile (8/8 batches) | Sterile | Endotoxin | <0.5 EU/mL (8/8 batches) | <0.5 EU/mL | Mycoplasma | Absent (8/8 batches) | Absent |
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