Comparison of Viral Clearance Results from Different Filter Lots. Repeat experiments using vendor-claimed analogs (longer being manufactured; see text for details) of filter lot B did not reproduce the cross-lot variability in PPV clearance previously observed (Table VI). All comparison experiments were carried out in duplicate to provide assurance of repeatability. M = midpoint of the range; L = low end of the range; and H = high end of the range. * Indicating reconstructed lot B filters; # derived from the DOE study (Table VI) using the original lot B filters.
| Experiment | Pressure (psi) | mAb (mg/mL) | Capacity (L/m2) | Filter Lot | LRF Achieved |
|---|---|---|---|---|---|
| 1 | M | M | M | *B | 6.83 |
| 2 | M | M | M | A | 6.36 |
| 3 | M | M | M | A | 7.19 |
| 4 | M | M | M | *B | 6.85 |
| #DOE 1 | M | M | M | B | 5.24 |
| #DOE 12 | M | M | M | B | 3.79 |
| 5 | L | L | H | *B | 7.67 |
| 6 | L | L | H | A | 7.70 |
| 7 | L | L | H | A | 6.26 |
| 8 | L | L | H | *B | 7.67 |
| #DOE 4 | L | L | H | B | 3.75 |