Table 3 Changes in Process C for different mAb production
mAb | mAb1 | mAb2 | mAb3 | mAb4 | ||||
|---|---|---|---|---|---|---|---|---|
Process | B | C | B | C | B | C | A | C |
N-2 seed | Batch in 50-L wave | Perfusion in 50-L wave | Batch in 50-L wave | Shake flasks | Batch in 50-L wave | Perfusion in 50-L wave | Batch in 50-L wave | Perfusion in 50-L wave |
N-1 seed | Batch in 200-L | Perfusion in 200-L | Batch in 200-L | Perfusion in 20-L | Batch in 200-L | Perfusion in 200-L | Batch in 200-L | Perfusion in 200-L |
Fed-batch production | 1000-L | 500-L | 1000-L | 5-L | 1000-L | 500-L | 1000-L | 500-L |
SD (× 106 cells/mL) | 3.0 | 16 | 3.0 | 15 | 4.5 | 10 | 1.5 | 15 |
Feed rate | Fixed at 3.1% of initial volume from Day 4 (D4) | Fixed at 4.1% of initial volume from D2 | Fixed at 3.5% of current volume from D3 | Fixed at 4% from current volume D1 | 2.6% D2–3; 3.5% D4–8; 2.46% D9–13 of initial volume | 2.6% D1; 3.54% D2–13; initial volume | Fixed at 3.6% of initial volume from D3 | Fixed at 4.5% of initial volume from D1 |
Temperature shift to | 32 °C on D5 | 32 °C on D3 | 34 °C on D6 | 34 °C on D4 | NA | NA | NA | 34 °C on D4 |