Factor VIII specific activity analysis
| FVIII Source and Dosage . | Hemophilic Mouse . | Sampling Time (PI) . | Coatest Assay (ng/mL) . | ELISA Assay (ng/mL) . | Specific Activity (U/μg) . |
|---|---|---|---|---|---|
| MiniAdFVIII 2.5 × 1011 vp/mouse | 12 | 3 d | 58 ± 39 | 105 ± 45 | 2.8 ± 1.3 |
| MiniAdFVIII 2.5 × 1011 vp/mouse | 12 | 6 d | 53 ± 17 | 106 ± 31 | 2.6 ± 0.6 |
| Recombinant FVIII 3.5 U/mouse | 2 | 1.5 h | 22 ± 11 | 24 ± 13 | 4.5 ± 0.2 |
| Recombinant FVIII 14 U/mouse | 2 | 1.5 h | 92 ± 30 | 149 ± 7 | 3.1 ± 0.8 |
| FVIII Source and Dosage . | Hemophilic Mouse . | Sampling Time (PI) . | Coatest Assay (ng/mL) . | ELISA Assay (ng/mL) . | Specific Activity (U/μg) . |
|---|---|---|---|---|---|
| MiniAdFVIII 2.5 × 1011 vp/mouse | 12 | 3 d | 58 ± 39 | 105 ± 45 | 2.8 ± 1.3 |
| MiniAdFVIII 2.5 × 1011 vp/mouse | 12 | 6 d | 53 ± 17 | 106 ± 31 | 2.6 ± 0.6 |
| Recombinant FVIII 3.5 U/mouse | 2 | 1.5 h | 22 ± 11 | 24 ± 13 | 4.5 ± 0.2 |
| Recombinant FVIII 14 U/mouse | 2 | 1.5 h | 92 ± 30 | 149 ± 7 | 3.1 ± 0.8 |
rFVIII specification: 1400 U/mL and 350 μg/mL, ie, 4 U/μg or 800 ng/μg, assuming 1 U = 200 ng/mL.