Medhealth insight

New Virus Filter Improves Biopharmaceutical Efficiency

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Asahi Kasei Medical, a global leader in biopharmaceutical manufacturing solutions, has launched the Planova™ FG1, a next-generation virus removal filter, to meet the growing demands of the biopharmaceutical industry. Released in October 2024, the Planova™ FG1 is designed to significantly enhance the efficiency and safety of the biotherapeutic production process, offering groundbreaking improvements in viral safety.

The Planova™ virus removal filters, a cornerstone of Asahi Kasei Medical’s bioprocess business, have been used in biopharmaceutical production since 1989. Over the years, the company has consistently improved its offerings, launching products such as Planova™ BioEX in 2009 and Planova™ S20N in 2022. The introduction of the Planova™ FG1 marks the next step in this evolutionary process, aimed at addressing the growing global demand for viral safety in biopharmaceuticals.

One of the standout features of the Planova™ FG1 is its significantly higher flux rate, which is approximately seven times greater than the Planova™ BioEX. This means faster filtration and reduced risk of virus breakthrough during the filtration suspension process. The increased flux rate is particularly important for manufacturers of monoclonal antibodies and other biopharmaceuticals, where the demand for efficient, large-scale filtration is rising as the sector continues to grow at an annual rate of 5-10%. The Planova™ FG1 provides a solution that can meet these demands while maintaining the highest safety standards for virus removal.

Customer evaluations during the product’s development phase confirmed its superior performance in terms of protein filtration and virus removal, even in the absence of a prefilter for aggregates. This feature helps streamline the filtration process, reducing operational complexity and increasing productivity. The filter is also designed to be fully compatible with cleaning-in-place (CIP) and sterilisation-in-place (SIP) processes, making it adaptable to a wide range of existing manufacturing systems. This versatility allows biopharmaceutical manufacturers to integrate the Planova™ FG1 with minimal disruption to their operations, enhancing overall productivity and efficiency.

The Planova™ FG1 is expected to play a key role in the production of biopharmaceuticals, especially as the industry shifts towards more complex biologics and gene therapies. Asahi Kasei Medical’s dedication to providing safe, efficient solutions is underscored by their plans to expand the product range to include larger filters that can accommodate process scaling. Mass production of the smaller Planova™ FG1 filters began in October 2024, with future plans to offer larger filters to meet the needs of large-scale production facilities.

Ken Shinomiya, President of Asahi Kasei Medical, expressed his enthusiasm about the new product, stating, “We are excited to introduce the Planova™ FG1 and to continue supporting the biopharmaceutical industry with our growing portfolio of innovative solutions. Our products are designed to ensure the safe, efficient manufacturing of biopharmaceuticals that patients can trust.”

With the launch of the Planova™ FG1, Asahi Kasei Medical continues to strengthen its position as a key player in the biopharmaceutical manufacturing industry, supporting the production of life-saving treatments with innovative, reliable, and efficient solutions.

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