| Metric | Standard Process (Benchmark) | Optimized Process (Case Study) | | :--- | :--- | :--- | | | 55% | 71% | | Cost of Goods (COG/g) | $150 | $78 | | Time to Tox (DNA to in vivo) | 11 months | 9 months | | Facility Footprint | 3 Skids (Capture, polish, virus) | 2 Skids (Intensified capture + polish) |
The team chose (Chinese hamster ovary) cells, the industry workhorse. For A Mab, they used a glutamine synthetase (GS) knockout system to eliminate ammonia build-up and enable selection with methionine sulfoximine (MSX).
Defines the multidimensional interaction of process variables that ensure product quality, allowing for more flexible regulatory filings and operational robustness. Control Strategy:
| Parameter | Lab (2 L) | Pilot (50 L) | Commercial (2,000 L) | |-----------|-----------|--------------|----------------------| | Temp (°C) | 37 → 33 (shift) | Same | Same | | pH | 7.0 → 6.9 (shift) | Same | Same | | DO (%) | 40 | 40 | 40 | | Agitation (tip speed) | 0.3 m/s | 0.35 m/s | 0.45 m/s | | Sparger type | Microsparger | Microsparger | Ring + micro |
At high concentrations, mAb-X became too viscous (thick and syrupy). This would make it difficult to inject through a thin needle.