High Applicability of Planova™ BioEX in the Continuous Process
October 19, 2021
Asahi Kasei Medical Co., Ltd.
Asahi Kasei Medical and Manufacturing Technology Association of Biologics have proved that Planova™ BioEX has high applicability in the mAb continuous process.
Asahi Kasei Medical is the global market leader in virus filtration, with its Planova™ 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.
Integrated continuous manufacturing processes have been investigated for years, making this step optimal for productivity and cost considerations. However, implementing a virus filtration in continuous bioprocessing is not a straightforward challenge due to concerns on the stability of long-term low-flux filtration and virus removal robustness caused by process pauses, such as when changing buffers. Integrating Planova™ BioEX (pool-less) can achieve efficient downstream processing with reduced footprint and process time under constant flow rate directly following flow-through column chromatography into continuous processes.
This research greatly expands the possibility of how the virus removal filter fits in continuous bioprocessing from an existing batch mode with tanks installed. Asahi Kasei Medical will continue to contribute to the greater safety of biotherapeutic products by developing high-quality and high-performance products.
Two articles on this study have been published in the open access journals: "Effect of mixed-mode and surface-modified column chromatography on virus filtration performance" in Biochemical Engineering Journal (https://doi.org/10.1016/j.bej.2021.108034), and "Analysis of filtration behavior using integrated column chromatography followed by virus filtration" in Biotechnology and Bioengineering (https://doi.org/10.1002/bit.27840).