Asahi Kasei Medical has launched the Planova FG1, a next-generation virus removal filter featuring higher flux for the manufacture of biotherapeutics.
The company's bioprocess business now comprises Planova virus removal filters and equipment used in the manufacturing process of biotherapeutic products such as biopharmaceuticals and plasma derivatives, biosafety testing services and biopharmaceutical CDMO operations. It is one of the Asahi Kasei Group’s businesses to drive future growth.
Sold since 1989, the Planova product lineup expanded in 2009 with the launch of Planova BioEX hydrophilic PVDF hollow-fiber membrane filters, and in 2022 with the launch of Planova S20N next-generation cellulose hollow-fiber membrane filters, meeting heightened standards for the viral safety of biotherapeutics around the world. The new Planova FG1 is expected to further contribute to improved productivity as demand for monoclonal antibodies and other biopharmaceuticals steadily grows by 5–10% per year.
Developed to maximize productivity in the process of manufacturing biopharmaceuticals, Planova FG1 provides high performance in terms of the filtration speed and robustness in virus removal capability. Its high flux is approximately seven times that of Planova™ BioEX, enabling virus filtration time to be shortened, and it features less risk of virus breakthrough when the filtration process is suspended. Customer evaluation in the development stage of Planova™ FG1 confirmed high protein filtration and virus removal performance under various conditions using several solutions, even without a prefilter to remove aggregates. Planova FG1 is also compatible with standard cleaning in place (CIP) and sterilization in place (SIP) processes, allowing it to be used with many types of existing equipment for biopharmaceutical manufacturing.
Following the October 2024 start of mass production and shipment of smaller filters of Planova FG1, Asahi Kasei Medical will successively extend the product lineup with new filters having larger surface areas to support its customers in efficiently scaling up their process. By adding Planova FG1 to its broad lineup of products, Asahi Kasei Medical will further solidify the presence of the Planova™ brand among biopharmaceutical manufacturers and contribute to the safer and more efficient production of pharmaceuticals.
“Asahi Kasei Medical is thrilled to launch the Planov FG1 next-generation virus removal filter,” says Ken Shinomiya, President of Asahi Kasei Medical. “We look forward to continuing to support biopharmaceutical manufacturers with our broad and growing lineup of products that help them to safely and efficiently manufacture pharmaceuticals that patients can trust.”
