Table 1A.
Accumulation of aggregates in MAB 1 during storage stability experiments as compared to RefmAb*
| Storage duration (months) | Storage temperature (°C) | Total% HMMS in MAB 1 | Total%HMMS in RefmAb |
|---|---|---|---|
| 0 | NA | 1.20 | 1.59 |
| 3 | 5 | 0.83 | 1.70 |
| 1 | 25 | 1.71 | 1.62 |
| 3 | 25 | 3.28 | 1.90 |
| 1 | 40 | 5.10 | 2.20 |
| 3 | 40 | 17.55 | 3.29 |
*
%HMMS stands for percent high molecular mass species. The value shown is the sum of all peaks that elute prior to the main peak in an SEC chromatogram. These peaks include dimers and higher order aggregates of the antibody molecule. Note that MAB 1 accumulates approximately 5x more aggregates than RefmAb when stored at 40°C for 3 months. Concentration of both the antibodies was 150 mg/ml. Both the mAbs were stored in the 20 mM histidine/histidine-HCl buffer, pH 5.8, 50mg/mL sucrose, 0.05 mg/mL Na2EDTA.2H2O, 0.2 mg/mL PS80.