Oxidation of mAb in Formulation (60 mg/mL) Spiked with Various Concentrations of H2O2 as Measured by RP-UHPLC
| Temperature (°C) | Time (months) | Final H2O2 Concentration (ng/mL) | |||||
|---|---|---|---|---|---|---|---|
| 0 (Control) | 50 | 100 | 200 | 300 | 3000 | ||
| Heavy Chain Fc Oxidation (%) | |||||||
| 2–8 | 0 | 3.6 | 3.5 | 3.6 | 3.6 | 3.6 | 5.8 |
| 1 | 3.6 | 3.8 | 3.8 | 4.2 | 4.3 | 11.5 | |
| 3 | 3.7 | 3.9 | 4.1 | 4.1 | 4.3 | 13.1 | |
| 6 | 3.4 | 3.6 | 3.7 | 4.4 | 4.4 | 13.5 | |
| 9 | 4.4 | 4.4 | 4.4 | 4.9 | 5.2 | 13.6 | |
| 12 | 4.4 | 4.6 | 4.8 | 4.8 | 5.3 | 13.3 | |
| Δ from T0 (12 months) | 0.8 | 1.1 | 1.2 | 1.2 | 1.7 | 7.5 | |
| 25 (60% RH) | 1 | 4.5 | 4.0 | 4.5 | 4.4 | 4.6 | 13.1 |
| 2 | 4.3 | 4.4 | 4.6 | 4.9 | 5.0 | 13.5 | |
| 3 | 4.7 | 5.0 | 5.1 | 5.5 | 6.0 | 14.2 | |
| 6 | 5.7 | 6.0 | 5.8 | 6.8 | 7.0 | 14.5 | |
| Δ from T0 (6 months) | 2.1 | 2.5 | 2.2 | 3.2 | 3.4 | 8.7 | |
| 40 | 0.25 | 3.8 | 4.0 | 4.3 | 4.7 | 4.8 | 12.6 |
| 0.5 | 4.4 | 4.6 | 4.4 | 5.1 | 5.2 | 12.8 | |
| 1 | 5.3 | 5.6 | 5.4 | 5.9 | 6.1 | 13.5 | |
| Δ from T0 (1 month) | 1.7 | 2.1 | 1.8 | 2.3 | 2.5 | 7.7 | |
| Heavy Chain Fab Oxidation (%) | |||||||
| 2–8 | 0 | 3.3 | 3.2 | 3.3 | 3.2 | 3.0 | 3.1 |
| 1 | 3.2 | 3.2 | 3.6 | 3.2 | 3.4 | 3.2 | |
| 3 | 3.1 | 3.4 | 2.9 | 2.8 | 3.0 | 2.9 | |
| 6 | 4.0 | 4.2 | 5.0 | 4.0 | 4.3 | 4.5 | |
| 9 | 3.8 | 3.9 | 3.6 | 3.6 | 3.6 | 3.6 | |
| 12 | 3.5 | 3.5 | 3.5 | 3.5 | 3.4 | 3.6 | |
| Δ from T0 (12 months) | 0.2 | 0.3 | 0.2 | 0.3 | 0.4 | 0.5 | |
| 25 (60% RH) | 1 | 4.5 | 3.6 | 3.6 | 3.7 | 3.5 | 3.6 |
| 2 | 3.6 | 3.6 | 3.8 | 3.7 | 3.8 | 3.8 | |
| 3 | 4.0 | 4.2 | 4.2 | 3.9 | 4.4 | 4.3 | |
| 6 | 7.3 | 7.3 | 8.5 | 6.9 | 6.6 | 6.7 | |
| Δ from T0 (6 months) | 4.0 | 4.1 | 5.2 | 3.7 | 3.6 | 3.6 | |
| 40 | 0.25 | 6.5 | 6.5 | 4.1 | 3.8 | 3.8 | 3.8 |
| 0.5 | 4.4 | 4.2 | 6.9 | 7.3 | 7.1 | 7.2 | |
| 1 | 6.1 | 5.7 | 6.0 | 6.0 | 8.7 | 9.3 | |
| Δ from T0 (1 month) | 2.8 | 2.5 | 2.7 | 2.8 | 5.7 | 6.2 | |
RH, relative humidity.