3.2.3. Viral clearance at low flux for Planova BioEX and Planova
S20N
For 24 h filtrations of 10 mg/mL mAb spiked with MVM on two sizes of
Planova BioEX and one size of Planova S20N to test low flux (1.5 - 10
LMH) conditions, complete MVM removal was achieved for all load and load
plus wash buffer as shown in Table 3. For the load fraction as well as
for the total load fraction plus buffer wash after the 60 min process
pause, MVM LRV of >5 was confirmed for all runs. Under
these low flux conditions, filtration pressure was extremely low, about
0.04 MPa at 5 LMH for Planova BioEX, and at 1.5 LMH, pressure was less
than 0.01 MPa for both Planova BioEX and S20N. These results confirm
that both Planova BioEX and S20N filters have robust virus removal
properties, even for very low flux filtrations with process pause, such
as in continuous process applications.