Table 4.
Fab concentrations determined by an antigen quantitative ELISA. Overall yields and recovery were calculated as a result of 2-step purification from three different productions.
| Production Batch | Purification Batch | Purification Step | Fraction | Fab Concentration (mg/mL) | Volume (mL) | Fab Amount (mg) | Total Process Recovery (%) | Average | STDEV | RSD |
|---|---|---|---|---|---|---|---|---|---|---|
| Production Batch 1 | Purification Batch 1 | First Step (AC) | Load | 0.163 | 48.234 | 7.863 | 50.38 | 49.59 | 1.53 | 3.09 |
| Second Step (CEX) | Elution | 0.990 | 4.000 | 3.961 | ||||||
| Purification Batch 2 | First Step (AC) | Load | 0.206 | 47.056 | 9.702 | 50.56 | ||||
| Second Step (CEX) | Elution | 1.226 | 4.001 | 4.905 | ||||||
| Purification Batch 3 | First Step (AC) | Load | 0.217 | 48.307 | 10.469 | 47.82 | ||||
| Second Step (CEX) | Elution | 1.252 | 4.000 | 5.006 | ||||||
| Production Batch 2 | Purification Batch 1 | First Step (AC) | Load | 0.164 | 48.170 | 7.914 | 51.95 | 50.27 | 1.63 | 3.24 |
| Second Step (CEX) | Elution | 1.370 | 3.001 | 4.112 | ||||||
| Purification Batch 2 | First Step (AC) | Load | 0.187 | 48.372 | 9.039 | 48.7 | ||||
| Second Step (CEX) | Elution | 1.046 | 4.208 | 4.402 | ||||||
| Purification Batch 3 | First Step (AC) | Load | 0.174 | 48.875 | 8.516 | 50.16 | ||||
| Second Step (CEX) | Elution | 1.067 | 4.002 | 4.272 | ||||||
| Production Batch 3 | Purification Batch 1 | First Step (AC) | Load | 0.204 | 48.285 | 9.845 | 47.55 | 48.11 | 0.93 | 1.93 |
| Second Step (CEX) | Elution | 1.872 | 2.500 | 4.681 | ||||||
| Purification Batch 2 | First Step (AC) | Load | 0.229 | 48.415 | 11.082 | 49.18 | ||||
| Second Step (CEX) | Elution | 1.362 | 4.001 | 5.450 | ||||||
| Purification Batch 3 | First Step (AC) | Load | 0.236 | 49.916 | 11.795 | 47.59 | ||||
| Second Step (CEX) | Elution | 1.403 | 4.000 | 5.613 |