Viral Clearance Results from a Lilly mAb-2 DOE Study Comparing Two Filter Lots. Experiments with filter lot A removed PPV better than those performed with lot B. Pressure, capacity, and mAb concentration were evaluated by DOE methodology in a full factorial manner. M = midpoint of the range; L = low end of the range; and H = high end of the range.
| Experiment | Pressure (psi) | mAb (mg/mL | Capacity (L/m2) | Filter Lot | LRF Achieved |
|---|---|---|---|---|---|
| 1 | M | M | M | B | 5.24 |
| 2 | M | M | M | B | 4.16 |
| 3 | L | H | L | B | ≥6.67 |
| 4 | L | L | H | B | 3.75 |
| 5 | H | L | H | B | 4.21 |
| 6 | H | H | L | B | 5.36 |
| 7 | L | L | L | A | 6.85 |
| 8 | L | H | H | B | 4.34 |
| 9 | H | H | H | A | 6.33 |
| 10 | H | L | L | A | 6.81 |
| 11 | M | M | M | B | 4.71 |
| 12 | M | M | M | B | 3.79 |