Table 7.
The analyses of mass, size and charge variants, aggregates, purity and biological activity of formulated Ranibizumab.
| Ranibizumab | Lucentis | ||
|---|---|---|---|
| Intact Mass (Da) | 48380 | 48380.199 ± 0.089 | |
| Reduced Mass | |||
| Light chain (Da) | 23432.5 ± 0.5 | 23432.48 ± 0.098 | |
| Heavy chain (Da) | 24956 | 24956.55 ± 0.049 | |
| CE-SDS | |||
| Light chain (%) | 0.965 ± 0.5 | ||
| Heavy chain (%) | 0.885 ± 0.065 | ||
| Intact Protein (%) | 97.95 ± 0.15 | 98.48 ± 0.16 | |
| SEC-HPLC | |||
| Main Peak (%) | 99.75 ± 19 | 99.640.34 | |
| IEX-HPLC | |||
| Acidic variant (%) | 0.14 ± 0.08 | ||
| Basic variant (%) | 0.765 ± 0.625 | ||
| Main peak (%) | 99.1 ± 0.7 | 99.57 ± 0.04 | |
| HUVEC relative potency (%) | 97.8 ± 0.7 | 98.47 ± 0.64 | |
| HCP level (ppm) | 0.07 ± 0.02 | 0.09 ± 0.02 | |
| Endotoxin Concentration (EU/mL) | <0.05 | <0.05 | |