Correspondence between small-scale filtration data and manufacturing-scale nanofilter performance is absolutely critical to be able to predict manufacturing process performance from process development experiments and for the validity of small-scale viral clearance validation studies. The scalability of nanofilters has been demonstrated previously using several performance metrics, but a comprehensive study directly showing uniformity of viral clearance has not been done previously. In this study, a direct evaluation of virus removal capabilities was performed on three parvovirus-grade filters. For each filter type, hollow fibers from three spinning series were manufactured into filters having effective surface area ranging from 0.0003 to 4.0 m2. The filters were evaluated for viral clearance capability using PP7 bacteriophage as a model for small virus contaminants. Robust viral clearance was consistently observed across all filter sizes with PP7 logarithmic reduction values (LRV) exceeding 4 log10 for all filtrations. These results demonstrate the excellent scalability of the virus filters, showing scalable filtration throughput and consistent virus removal capacity across all sizes. These findings support the application of small-scale viral clearance studies to validate and optimize virus filtration processes at larger scales.

Direct demonstration of scalability of virus removal filter performance

253rd National Meeting (2017)

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