Table 1.
Accelerated stability studies of Bs4Ab-VA, anti-VEGF and anti-Ang2 parental antibodies at 25 mg/mL and 4°C, 25°C and 40°C for one month.
| Analyte | Concentration (mg/mL) | Temperature (°C) | Purity loss after 1 week (%) | Purity loss after 2 weeks (%) | Purity loss after 4 weeks (%) |
|---|---|---|---|---|---|
| Bs4Ab-VA | 25 | 4 | 0 | 0.2 | 0.4 |
| 25 | 0.5 | 1.0 | 1.4 | ||
| 40 | 1.5 | 6.0 | 10 | ||
| anti-VEGF | 25 | 4 | 0 | 0.1 | 0.5 |
| 25 | 0.1 | 0.2 | 0.7 | ||
| 40 | 0.3 | 0.4 | 4 | ||
| anti-Ang2 | 25 | 4 | 0.2 | 0.4 | 0.8 |
| 25 | 0.4 | 2.0 | 4.0 | ||
| 40 | 10 | 14 | 22 |
Purity loss represents the percentage of the sum of aggregates and fragments as determined by analytical SEC-HPLC. All analytes were subjected to 3 cycles of freeze-and-thaw before the accelerated stability studies. All analytes were formulated in 25 mM Histidine-HCl, 0.8% Sucrose, 0.02% Polysorbate-80, pH 6.0.