Operating Parameter Summary for the Three CHT Chromatography Processes
| Operating Parameter | mAb 1 | mAb 2 | mAb 3 |
|---|---|---|---|
| Column position within process | 3rd of 3 | 3rd of 3 | 3rd of 3 |
| Load material | AEX product | Neutralized low pH product | Neutralized low pH product |
| Chromatography medium type | Bio-Rad CHT type II (40 μm) | Bio-Rad CHT type I (40 μm) | Bio-Rad CHT type I (40 μm) |
| Column height (cm) | 10.0 | 14.6a and 15.8b | 13.7 |
| Column diameter (mm) | 11.5 | 11.5 | 11.5 |
| Linear flow rate (cm/h) | 180 | 240 | 350 |
| Load challenge (g mAb/L resin) | 22 | 37 | 35 |
| Load concentration (g/L) | 4.0 | 4.0a and 5.6b | 4.8 |
| Load pH | 6.7 | 7.9 | 7.8 |
| Load conductivity (mS/cm) | 4.3 | 5.9a and 6.0b | 5.3 |
| Equilibration buffer | 20 mM Tris-HCl, pH 7.1 | 20 mM Tris-HCl, pH 7.8 | 20 mM Tris-HCl, pH 7.5 |
| Elution buffer | 20 mM sodium phosphate, 200 mM sodium chloride, pH 7.8 | 20 mM sodium phosphate, 100 mM sodium chloride, pH 7.8 | 20 mM sodium phosphate, 200 mM sodium chloride, pH 7.4 |
↵a: XMuLV study; b: PRV, SV40, and PPV study.