2.2.3. MVM spike of low flux filtration on Planova BioEX and S20N filters
Viral clearance studies of the mAb were conducted on 0.001 and 0.0003 m2 Planova BioEX filters, which has a hydrophilic modified polyvinyldene flouride (PVDF) hollow fiber, and on the 0.001 m2 Planova S20N filter (Asahi Kasei Medical), which is a newly launched filter with hollow fibers made from regenerated cellulose. In this study, all runs were conducted at low flux of 1.5, 5 and 10 LMH for Planova BioEX and 1.5 LMH for Planova S20N as shown in Table 3. For all runs, 10 mg/mL mAb spiked with 1% MVM (0.1 μm prefiltered) was filtered for 24 h. The spike solution was loaded to the filter using the sample pump of AKTA pure 25. Following mAb load filtration and a 60 min process pause, 10 mL or 5 mL of equilibration buffer wash was conducted for the 0.001 m2 or 0.0003 m2 filters, respectively. Viral clearance was measured for the mAb load permeate and total permeate with buffer wash.