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 m² 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.

生物制药制造中的病毒去除过滤过程是使用实验室规模的过滤器开发、优化和验证病毒清除的。因此，这些过滤器的可扩展性对于准确推断过滤性能和可靠地将病毒清除率扩展到制造规模至关重要。除病毒过滤器制造商通常根据各种过滤参数验证过滤性能的可扩展性，并且病毒去除能力扩展到使用惰性、尺寸合适的颗粒（例如金纳米粒子）制造规模的过滤器，以避免与在大量进料中使用哺乳动物病毒相关的风险. 在这项研究中，我们使用噬菌体 PP7 作为细小病毒模型来直接证明在所有尺度的 Planova™ BioEX 病毒去除过滤器上的病毒清除，包括制造规模。三个纺丝系列中空纤维过滤器，过滤器尺寸从 0.0003 到 4.0 m²使用掺有 PP7 的 BSA 测试了病毒去除、通量和蛋白质回收性能。在所有过滤器尺寸中观察到完全病毒清除，PP7 LRV ≥ 4.7 或更高。通量和蛋白质回收率也一致。这些结果证明了过滤性能的可扩展性和所有尺寸的一致病毒去除，支持使用实验室规模的过滤器来验证制造规模的病毒清除。