Design for Low pH and XMuLV Inactivation Experiment(s)
| Variables/Parameters | Low pH stability Experimental Value | XMuLV Inactivation Experimental Value |
|---|---|---|
| Molecules | 4 monoclonal antibodies (mAbs) and 1 Fc fusion | mAb A |
| pH | 3.2, 3.3, 3.4, and 3.5 | 3.4, 3.5, and 3.6 |
| Time points (min) | 2, 4, 8, 15, 30, (60) | 0.5, 1.5, 3, and 10 (large volume) |
| Acid titrant | 1 M or 2 M acetic acid | 1 M acetic acid |
| Protein A elution buffer | 10 or 100 mM sodium acetate | 20 mM sodium acetate |
| Protein concentration (g/L) | 10–20 | 12 g/L |
| Temperature | 25°C (water bath) | 15°C (water bath) |