Testing with Mab-A Compared Multiple Filter Lots in Order To Examine Lot-to-Lot Variability
| Product | Run | Load pH | Loading (L/m2) | Log10 Reduction (X-MuLV) | Log10 Reduction (MMV) |
|---|---|---|---|---|---|
| Mab-A | A | 6.5 | 100 | ≥5.03 | 1.45 |
| Mab-A | B | ≥5.10 | 1.14 | ||
| Mab-A | C | ≥5.07 | 1.23 | ||
| Mab-A | D | ≥5.69 | 2.1 | ||
| Mab-A | E | ≥5.69, 6.51 | 2.04, 3.04 | ||
| Mab-E | A | 6.8 | 100 | ≥4.66 | 3.34 |
| Mab-E | B | ≥4.77 | 3.13 | ||
| Mab-B | A | 7.2 | 60 | ≥5.39 | 6.05 |
| Mab-B | B | ≥5.40 | 6.93 |
For Mab-A, Run E, duplicate studies were performed using a single filter lot. An air blowdown was incorporated into the second study to evaluate the impact on viral clearance. For Mab-E and Mab-B, two independent studies were performed with a single filter lot.