Virus filter scalability: Demonstration of consistent viral clearance across laboratory and manufacturing scales. (July 2021)

• Record Type: Journal Article
• Authors: Buesing, Brian; Schwartz, Alex; Shah, Aesha; Sohka, Takayuki; Hirotomi, Naokatsu; Strauss, Daniel
• Is Part Of: Biologicals. Volume 72(2021)
• Page Start: 27
• Page End: 32
• Publication Date: 2021-07
• Subjects: Scalability -- Bacteriophage PP7 removal -- Virus filtration; Biological products -- Standards -- Periodicals; Biological Products -- Periodicals; Biological Products -- standards -- Periodicals; Produits biologiques -- Normes -- Périodiques; Biological products -- Standards; Periodicals; 615.37
• DOI: 10.1016/j.biologicals.2021.05.004
• Languages: English
• ISSNs: 1045-1056

Abstract

Abstract: Virus removal filtration processes in biopharmaceutical manufacturing are developed, optimized and validated for viral clearance using laboratory scale filters. Thus, the scalability of these filters is critical for accurately extrapolating filtration performance and reliably extending viral clearance to manufacturing scale. Virus removal filter manufacturers generally validate scalability of filtration performance based on various filtration parameters, and virus removal capability is extended to manufacturing scale filters using inert, size-appropriate particles such as gold nanoparticles to avoid the risks associated with using mammalian viruses in large feed volumes. In this study, we use bacteriophage PP7 as a parvovirus model to directly demonstrate viral clearance on Planova™ BioEX virus removal filters across all scales, including manufacturing scale. Filters with hollow fibers from three spinning series with filter sizes ranging from 0.0003 to 4.0 m 2 were tested for virus removal, flux, and protein recovery performance using BSA spiked with PP7. Complete viral clearance was observed across all filter sizes with PP7 LRV of ≥4.7 or higher. Flux and protein recovery were also consistent. These results demonstrate the scalability of filtration performance and consistent virus removal at all sizes, supporting the use of laboratory scale filters to validate viral clearance at manufacturing scales.