Aphios Granted Japanese Patent for Inactivating Viruses and Other Pathogens in Biologics and Human Plasma
April 07, 2009
Woburn, MA— Aphios Corporation today announced that it was granted a Japanese patent for an improved method of inactivating viruses and other pathogens in biologics such as monoclonal antibodies, recombinant therapeutics, human plasma and plasma proteins.

The Aphios method is purely physical and does not utilize organic solvents, heat, irradiation, and/or chemicals commonly used in commercially available virus inactivation techniques. As such, therapeutic proteins and enzymes retain structural and biological integrity, and products are left without traces of denaturing solvents or potentially mutagenic chemicals.

The method utilizes supercritical, critical, or near-critical fluids with or without cosolvents (SuperFluids™ or SFS). SuperFluids™ are normally gases which, when compressed, exhibit enhanced solvation, penetration and expansion properties. These fluids are used to permeate and inflate virus particles (virions) and other pathogens. The overfilled particles are then decompressed and, as a result of rapid phase conversion, rupture at their weakest points. Like a scuba dive rising faster than generated bubbles, virions are given the "bends" and become inactive.

Research to date indicates that the SuperFluids™ CFI (critical fluid inactivation) inactivates enveloped viruses such as MuLV, VSV, TGE, BDVD, Sindbis and HIV in protein-rich liquid media by a lipid solubilization mechanism, similar to that of the solvent detergent method. Research also indicates that SFS-CFI inactivates non-enveloped viruses surrounded by a tough protein capsid through rapid expansion of SuperFluids™ within the virus with concomitant physical disruption of viral particles. SFS-CFI's ability to inactivate non-enveloped viruses such as Polio, Adeno, Reo, Parvo and EMC in protein-rich media, while preserving biological activity of the treated product, has been demonstrated. In a research collaboration with the National Institute of Biological Standards and Control (NIBSC), London, England, scientists have demonstrated that SuperFluids™ CFI can inactivate more than 4 logs of human Parvovirus B19 in human serum. The CFI process can inactivate between 1 and 6 logs of most enveloped and non-enveloped viruses in a single stage unit in less than 20 seconds. Inactivation levels can be increased to > 6 logs by adding more stages.

Dr. Castor, lead inventor of this technology, states that "With a uniquely physical mechanism of action, CFI can be used as an orthogonal method with other virus inactivation techniques to eliminate emerging viruses and other unknown pathogens from biologics and human plasma."

Aphios Corporation is a biotechnology company that is developing enabling technology platforms for improved drug discovery, manufacturing, delivery and pathogen safety, and enhanced therapeutic products for health maintenance, disease prevention and the treatment of certain cancers, infectious diseases and CNS disorders.

Research leading to the development of this technology was funded by an Advance Technology Program (ATP) grant from the National Institute of Standards and Testing (NIST), US Department of Commerce, and Small Business Innovative Research (SBIR) grants from the National Science Foundation (NSF) and the National Institutes of Health (NIH). The content of this release is solely the responsibility of the authors and does not necessarily represent the official views of NIST, NSF or NIH.