News
The Implementation of serial virus filtration provides highly desired viral safety robustness while maintaining process complexity
Feb 09, 2024
Feb 9, 2024
Asahi Kasei Medical Co., Ltd.
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, done in collaboration with CSL Behring, showing the high applicability of Planova™ virus removal filters in a serial setting for two challenging molecule types.
Virus filtration is a crucial step in ensuring the viral safety of biopharmaceutical products and utilizes a size exclusion mechanism for a wide range of virus types. Depending on the product type, process conditions or a combination thereof, achieving the desired viral clearance may be challenging when using a single virus filter. When implementing not one, but two or more virus removal filters, a number of critical parameters must be taken into consideration in order to design an optimal process.
Kozaili and her team partnered with CSL Behring to investigate multiple filter combinations to identify an optimal process for two molecule types. Our results showed that an efficiently designed serial filtration process can deliver a highly desired robust viral clearance step, with minimal risk to the process, and can be applicable to not only constant pressure but also constant flow configurations, such as in integrated continuous processing.
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 Journal.
Title: Serial virus filtration: A case study evaluating the product-dependent impact of control strategies on process efficiency
(Open Access: https://doi.org/10.1002/biot.202200599)
Virus filtration is a crucial step in ensuring the viral safety of biopharmaceutical products and utilizes a size exclusion mechanism for a wide range of virus types. Depending on the product type, process conditions or a combination thereof, achieving the desired viral clearance may be challenging when using a single virus filter. When implementing not one, but two or more virus removal filters, a number of critical parameters must be taken into consideration in order to design an optimal process.
Kozaili and her team partnered with CSL Behring to investigate multiple filter combinations to identify an optimal process for two molecule types. Our results showed that an efficiently designed serial filtration process can deliver a highly desired robust viral clearance step, with minimal risk to the process, and can be applicable to not only constant pressure but also constant flow configurations, such as in integrated continuous processing.
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 Journal.
Title: Serial virus filtration: A case study evaluating the product-dependent impact of control strategies on process efficiency
(Open Access: https://doi.org/10.1002/biot.202200599)
