Particle-based analysis unveils principal causes for inconsistency in virus filter performance! A new reliable approach to virus clearance study design with Planova™
February 2, 2022
Asahi Kasei Medical Co., Ltd.
Asahi Kasei Medical Corporation is pleased to announce that research findings of the first-ever particle-based quantitative demonstration of the virus retention capacity of PlanovaTM virus removal filters elucidate the cause of inconsistency in virus filter performance for virus removal validation.
Asahi Kasei Medical is the global market leader in virus filtration, with its PlanovaTM filters having an unrivaled 30-year history of trusted use in the production of biotherapeutics. We aim to provide "Assurance Beyond Expectation" to ensure product safety and manufacturing efficiency for therapeutics within the biopharmaceutical industry in the form of innovative yet exceptionally reliable bioprocess consumables, equipment and related scientific support, and biosafety testing services.
The virus filtration process using a virus filter (VF) is one of the most robust virus removal processes based on the size exclusion mechanism. However, we have seen marked variation in virus removal performance for VFs even with identical virus clearance study (VCS) design, including the same protein materials and operating conditions. This inconsistency is one of the major issues to optimize VCS design for users of VFs, including PlanovaTM.
The present study developed a particle number-based method for VCS and elucidated real virus retention capacities of PlanovaTM filters. In addition, the relativity of conventional infectivity quantification and competitive captures of virus particles that do not have infectivity have been shown to make it difficult to determine the exact amount of virus removed by PlanovaTM, resulting in inconsistency in virus removal performances with infectivity-based evaluations.
This study is expected to make a contribution to the development of biopharmaceuticals and their manufacturing processes by eliminating inconsistency in virus removal validation and providing a reliable back-calculation approach to design virus clearance study using PlanovaTM. Asahi Kasei Medical will continue to contribute to the greater safety of biotherapeutic products by developing high-quality and high-performance products in accordance with market needs.
The article "Particle-based analysis elucidates the real retention capacities of virus filters and enables optimal virus clearance study design with evaluation systems of diverse virological characteristics" has been published in Biotechnology Progress on January 22, 2022. On publication, the paper has been freely available online at https://doi.org/10.1002/btpr.3237.