Table 1.
Quality Control of Intermediate and Final Product
| Test item | Tests | Method | Laboratory | Results |
|---|---|---|---|---|
| Purified bulk | Vector genome (vg/ml) | qPCR | UMR1089 | 5.7×1012 vg/ml |
| Bioburden | EP 2.6.12 | SGS-Vitrology | 0 cfu/ml | |
| Endotoxin | EP 2.6.14 | SGS-Vitrology | <0.03 EU/ml | |
| Mycoplasma | EP 2.6.7 | SGS-Vitrology | Negative | |
| Final product | Vector genome (vg/ml) | qPCR | UMR1089 | 6.4×1011 vg/ml |
| Vector genome (vg/ml) | Dot blot | UMR1089 | 6.3×1011 vg/ml | |
| Transducing units (TU/ml) | Transduction of cells; GFP read out | UMR1089 | 1.5×108 TU/ml | |
| Sterility | EP 2.6.1 | SGS-Vitrology | Sterile |
qPCR, quantitative polymerase chain reaction.