The outstanding performance of Planova virus removal filters in manufacturing operations is supported by studies at small scale. Correspondence between small-scale filtration data and manufacturing-scale filter performance is absolutely critical for predicting manufacturing process performance from process development experiments and for assuring the validity of small-scale viral clearance validation studies. The scalability of Planova filters has been demonstrated for several performance metrics, but a comprehensive study demonstrating consistent viral clearance over the range of filter sizes has not been previously exhibited. In this study, Planova 20N and BioEX hollow fibers from each of three spinning series were manufactured into filters with effective surface areas covering the range of commercially available filters (4.0 to 0.001 m2 for Planova 20N and 4.0 to 0.0003 m2 for Planova BioEX). Feed solutions of 1 g/L BSA spiked with PP7 bacteriophage as a model parvovirus were filtered to 200 L/m2, and each Planova filter was evaluated for throughput and viral clearance capability. Overall, average flow rate showed direct proportionality with effective surface area, and all filtrations showed complete clearance with PP7 logarithmic reduction value (LRV) exceeding 4 log10. These results demonstrate the excellent scalability of Planova virus removal filters and support the use of small-scale filters to validate viral clearance at larger scales.

Linear scalablity of Planova BioEX and Planova 20N filters

255th National Meeting (2018)

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