Category | Parameter | Process A | Process B | Process C |
---|---|---|---|---|
Media | Seed expansion | B1 + MSX | B1 + MSX | B1 + MSX |
Production basal | B1 | B1 or B1 enriched | B2 or B2 enriched | |
Feed | F1 | 1.3 × F1 or 1.3 × F1 enriched | F2 or F2 enriched | |
Process mode | N-2 seed | Batch | Batch | Perfusion or batch |
N-1 seed | Batch | Enriched batch or fed-batch | Perfusion | |
Production (N) | Conventional fed-batch | Intensified fed-batch with non-perfusion N-1 | Intensified fed-batch with perfusion N-1 | |
Production process parameters | Inoculation density (× 106 cells/mL) | 0.3–1.5 | 3.0–6.0 | 10–20 |
Feeding strategy | Fixed at 3.6% of initial volume from Day 3 | Variable | Variable | |
Temperature shift | No | Variable | Variable | |
Harvest | Day | Day 14 | Day 10–14 | Day 10–14 |
Process yield | Final normalized titer | 0.1–0.3 | ~ 0.5 | ~ 1.0 |