Based on the linear scalability of performance parameters for virus removal filters used in pharmaceutical manufacturing, validation studies conducted at small scale are expected to accurately predict performance at manufacturing scale. The scalability of nanofilter performance has been demonstrated by several metrics, but a comprehensive study directly showing uniformity of viral clearance among a variety of filter sizes has not been done previously. In this study, hollow fibers from a single spinning series, used to make Planova™ filters, were manufactured with effective surface areas ranging from 0.001 to 4.0 m2. Filters from three spinning series for each tested filter type were tested for virus removal performance by using a solution of PP7 bacteriophage as a model parvovirus. Robust viral clearance was consistently observed across all filter sizes and for all filter types used with LRV results exceeding 4 log10 for all filtrations. These results establish the scalability of these virus removal filters, demonstrating their excellent performance in manufacturing operations and supporting the application of small scale filters to validate viral clearance at larger scales. Having demonstrated the benefits of this type of study, continued work should focus on generating similar data concerning all virus removal filters.

Nanofilter scalability: A comprehensive look into viral clearance capabilities at all sizes

251st National Meeting (2016)

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.