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Demonstrating the applicability of Planova™ virus removal filters in an end-to-end integrated continuous process

Jul 20, 2023

July 20, 2023
Asahi Kasei Medical Co., Ltd.
Asahi Kasei Medical Co., Ltd. (Headquarters: Chiyoda-ku, Tokyo; President: Ken Shinomiya) is pleased to announce the publication of a study showing the high applicability of Planova™ virus removal filters in a continuous process for monoclonal antibody (mAb) production done in collaboration with the Manufacturing Technology Association of Biologics (MAB).

Asahi Kasei Medical is the global market leader in virus filtration, with its Planova™ 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 purification consumables, equipment and support services.

Continuous processes have been shown to increase productivity while reducing costs in the production of recombinant proteins, of which mAbs are the most common. End-to-end integrated continuous processes span from upstream cell culture to the final purification steps downstream, including virus filtration.

However, incorporating virus filtration into continuous processes has proven to be a challenge due to their typically long durations operated under constant flow with variable feed streams and process pauses for buffer exchanges, which are all factors that have the potential to impact the virus removability of the filter. We partnered with MAB to examine the incorporation of a Planova BioEX filter after a total flow‐through integrated polishing process without pooling (i.e., tankless). In this constant flow rate process conducted over an extended period of time, Planova BioEX filters showed robust virus removal capability and stable filtration performance, even with process pauses. Thus, Planova BioEX filters can be incorporated into end-to-end integrated continuous processes.

Through this study, we were able to show that the effective use of virus removal filters is not limited to constant flow batch processes with tanks and that more efficient pharmaceutical production methods are possible. As a company, we plan to continue our efforts and endeavors into research and development, creating high quality and functional products to ensure the safety of biotherapeutics worldwide.

*This study is published in Biotechnology and Bioengineering.
Title: Viral clearance in end‐to‐end integrated continuous process for mAb purification: Total flow‐through integrated polishing on two columns connected to virus filtration
(Open Access: