BIOT 114 |
| In a recombinant monoclonal antibody purification process, the typical technologies used for viral clearance include chromatography, chemical inactivation, and membrane filtration. This presentation will review process development data for parvovirus clearance membrane filtration for a late stage antibody product. The requirement for high mass throughput, regulatory compliance and lower cost of production make the use of high throughput virus clearance filters attractive. Studies were done to compare the performance of two parvovirus clearance filters: a newly developed filter, Viresolve Pro™ and an existing filter, Viresolve NFP™. The study focused on exploring the optimal operating parameters to achieve high throughput within a short operation time. Factors taken into consideration for the study were different in-process pools, product pool condition (fresh vs. frozen/thawed samples), product concentration, filtration operating mode (constant flux vs. constant pressure), different operating fluxes, and using two different aggregate reducing technologies. Results show that with proper optimization, mass throughputs of up to 15kg/m2 may be achieved with the Viresolve Pro filter, with or without prefiltration. Data will also be presented on the plugging mechanisms and capacity of the two virus filters at multiple operating fluxes and pressures, as well with the different prefilters. Viral spiking study results will also be included to demonstrate virus clearance under actual process conditions. |
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Downstream Processing: Non-Chromatographic Separations
1:30 PM-4:20 PM, Monday, August 18, 2008 Philadelphia Marriott -- Grand Blrm Salon H, Oral
Division of Biochemical Technology |