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Asahi Kasei Corporation Unveils Planova™ 20N Filter for Removal of Small Viruses from Large-Molecule Biotherapeutic Products

Asahi Kasei Corporation (formerly Asahi Chemical Industry Co., Ltd.) today introduced the Planova™ 20N filter, designed to retain small non-enveloped viruses, such as parvovirus and hepatitis A virus (HAV), with virus removal factors in excess of 4 logs, while providing high recovery rates for proteins, including plasma-derived immunoglobulin (IgG), Factor VIII, and fibrinogen.

Biotherapeutic product manufacturers and regulatory authorities alike have drawn attention to the limitations of current methods to remove or inactivate non-enveloped viruses across a range of biotherapeutic products with varying molecule sizes and physico-chemical properties. The Planova™ 20N filter removes significant levels of even the smallest of these viruses using size exclusion, irrespective of virus properties.

"The unique structure of the Planova™ 20N membrane enables greater volumes per surface area unit to be effectively cleared of viruses," said Yasuichiro Yano, General Manager, Planova™ Division at Asahi Kasei. "This results in a filtration profile unmatched by comparable products currently available on the market."

Viral challenge studies of the Planova™ 20N filter employing porcine parvovirus (PPV) and poliovirus showed log reduction values (LRV) of greater than 4.7 logs and 8.0 logs, respectively.

Protein permeability studies with the Planova™ 20N filter demonstrated product recovery rates of greater than 99% for plasma-derived immunoglobulin (IgG).

Asahi Kasei Corporation introduced its first Planova™ filter in 1989 as the world's first filter specifically designed to remove viral material from biopharmaceutical and plasma-derived products. The Planova™ filter product family currently includes four filters--Planova™ 15N, Planova™ 20N, Planova™ 35N, and Planova™ 75N filters.

All Planova™ filters utilize a hollow-fiber microporous membrane composed of naturally hydrophilic cuprammonium-regenerated cellulose inside a polycarbonate housing. Each Planova™ filter is integrity tested prior to factory release, and can be integrity tested prior to and following filtration. Designed for use in Good Manufacturing Practice (GMP) environments, Planova™ filters are available in a range of membrane surface areas to facilitate scale-up from laboratory studies to process scale.

About Asahi Kasei Corporation
Asahi Kasei Corporation, headquartered in Tokyo, Japan, is a US$10 billion technology company, providing innovative, science-based solutions to a diverse range of markets including chemicals and plastics, apparel, housing and construction, health care, and electronics.