Research Article
Tips and Tricks for Validation of Quality Control Analytical Methods in Good Manufacturing Practice Mesenchymal Stromal Cell Production
Table 3
Preliminary endotoxin test on the interfering factors on the final product at different dilutions.
| | Parameters | Product dilution | Negative control (LRW) | Acceptance criteria | | 1_30 | 1_90 | 1_180 |
| | Onset time sample no spike | >1039 | >1039 | >1039 | >1039 | >1039 | | CV between sample replicates (%) | 0 | 0 | 0 | 0 | <10% | | CV between spike replicates (%) | 1.3 | 5.6 | 2.3 | 0 | <10% | | Spike recovery (%) | 115 | 122 | 114 | np | 50%–200% | | Sample value (EU/mL) | <0.15 | <0.45 | <0.9 | np | <EL |
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