Monoclonal Antibody Drug Substance Formulations Used in Stress Mechanism Identification Studies1
| API | mAb Concentration (mg/mL) | Trehalose Concentration (mM) | Sucrose Concentration (mM) | NaCl Concentration (mM) | Buffer X Concentration (mM) | Buffer Y Concentration (mM) |
|---|---|---|---|---|---|---|
| mAb A1 | 25 | 0 | 150 | 0 | 25 | 0 |
| mAb A2 | 25 | 0 | 0 | 150 | 25 | 0 |
| mAb B | 100 | 25 | 0 | 0 | 0 | 150 |
| mAb C | 100 | 25 | 0 | 0 | 0 | 150 |
↵1 All formulations contained surfactant at concentrations above critical micelle concentration level.