IT characteristics
| . | SPV-T3a-dgA (CD3) . | WT1-dgA (CD7) . |
|---|---|---|
| MoAb | murine IgG2b | murine IgG2a |
| Composition (SDS-PAGE) | MoAb(dgA)≥3 (6%) | MoAb(dgA)≥3 (0%) |
| MoAb(dgA)1-2 (88%) | MoAb(dgA)1-2(78%) | |
| MoAb 6% | MoAb 23% | |
| dgA 0% | dgA 0% | |
| Sterility | Sterile | Sterile |
| Endotoxins (EU/mg protein) | <0.8 | <0.7 |
| DNA content (pg/mg protein) | <11 | <9 |
| Protein A (ng/mg protein) | 1.1 ± 0.3 | 2.7 ± 0.8 |
| Cybacron blue (nmol/L) | <10 | <10 |
| A-chain activity (% native dgA) | 84 | 91 |
| Binding activity (% native MoAb) | 70 | 90 |
| Dissociation in human plasma at 37°C (% in 24 h) | 10 | 10 |
| In vitro cross-reactivity | Esophagus epithelium (++) | Kupfer cells (+/−) |
| Smooth muscle cells (+/−) | ||
| LD50 | 25-45 μg/g mouse for the IT-combination | |
| Toxicity cynomolgus monkey | Reversible increase of CK levels on administration of human doses IT combination (0.1-0.25 mg/kg) | |
| . | SPV-T3a-dgA (CD3) . | WT1-dgA (CD7) . |
|---|---|---|
| MoAb | murine IgG2b | murine IgG2a |
| Composition (SDS-PAGE) | MoAb(dgA)≥3 (6%) | MoAb(dgA)≥3 (0%) |
| MoAb(dgA)1-2 (88%) | MoAb(dgA)1-2(78%) | |
| MoAb 6% | MoAb 23% | |
| dgA 0% | dgA 0% | |
| Sterility | Sterile | Sterile |
| Endotoxins (EU/mg protein) | <0.8 | <0.7 |
| DNA content (pg/mg protein) | <11 | <9 |
| Protein A (ng/mg protein) | 1.1 ± 0.3 | 2.7 ± 0.8 |
| Cybacron blue (nmol/L) | <10 | <10 |
| A-chain activity (% native dgA) | 84 | 91 |
| Binding activity (% native MoAb) | 70 | 90 |
| Dissociation in human plasma at 37°C (% in 24 h) | 10 | 10 |
| In vitro cross-reactivity | Esophagus epithelium (++) | Kupfer cells (+/−) |
| Smooth muscle cells (+/−) | ||
| LD50 | 25-45 μg/g mouse for the IT-combination | |
| Toxicity cynomolgus monkey | Reversible increase of CK levels on administration of human doses IT combination (0.1-0.25 mg/kg) | |
SDS-PAGE indicates sodium dodecyl sulfate-polyacrylamide gel electrophoresis.