Table IV

Initial Viral Clearance Results from Lilly mAb-1 DOE Study, Exhibiting Sporadic Breakthrough of PPV. 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	mAb (mg/mL)	Capacity (L/m²)	Pressure (psi)	LRF Achieved
1	M	M	M	≥6.26
2	L	L	H	6.54
3	H	H	H	≥6.34
4	M	M	M	≥6.71
5	M	M	M	≥6.71
6	L	H	L	≥6.73
7	H	L	H	≥6.36
8	L	H	H	2.56
9	M	M	M	≥6.70
10	H	L	L	≥6.45
11	H	H	L	≥6.44
12	L	L	L	≥6.69