Table 3.
Summary of the physicochemical analysis results for SB11 and EU/US-ranibizumab
| Analysis | Attributes | SB11 | EU-ranibizumab | US-ranibizumab |
|---|---|---|---|---|
| SE-HPLC | %Monomer (%) | 99.9–100.0 | 99.9–100.0 | 99.8–99.9 |
| %HMW (%) | 0.0–0.1 | 0.0–0.1 | 0.1–0.2 | |
| CE-SDS (non-reduced) | %Main (%) | 99.3–99.4 | 99.0–99.1 | 98.8–98.9 |
| CE-SDS (reduced) | %Main1 (%) | 42.7–43.0 | 43.0–43.1 | 43.0–43.1 |
| %Main2 (%) | 56.5–56.8 | 56.8–56.9 | 56.7–56.8 | |
| icIEF | pI | 8.2 | 8.2 | 8.2 |
| %Acidic (%) | 3.1–4.1 | 3.2–3.9 | 2.9–3.6 | |
| %Main (%) | 93.9–95.3 | 94.2–95.4 | 94.5–95.5 | |
| %Basic (%) | 1.6–1.9 | 1.4–1.9 | 1.4–1.8 |