Consumption Rates (reciprocal month) of Peroxide in mAb Formulations Spiked with 1000 ng/mL H2O2
| Formulation | Protein Concentration (mg/mL) | Peroxide Consumption (Rate constant; k) | 95% Confidence Intervals of Peroxide Consumption Rate (Based on observed values) | ||
|---|---|---|---|---|---|
| Theoretical (using mAb1 as standard) | Observed (from spiking studies) | Upper Limit | Lower Limit | ||
| mAb1 | 10 | 0.10 | 0.10 | NA | NA |
| mAb2 | 25 | 0.25* | 0.33 | 0.40 | 0.26 |
| mAb3 | 200 | 2.00* | 2.86 | 3.59 | 2.12 |
↵* Calculated based on mAb1 rate observed from spiking study performed at 5 °C.
NA = not applicable.