Aphios Granted US Patent for Inactivating Viruses and Other Pathogens in Human Plasma and Blood Products
November 04, 2002
Woburn, MA — Aphios Corporation has been granted United States Patent No. 6,465,168 on October 15, 2002 for "Methods and Apparatus for the Inactivation of Viruses."

Inactivation of pathogenic viruses is a major healthcare concern. Viruses of concern include the enveloped HIV, the nonenveloped hepatitis A virus, and new "hot zone" viruses, which may have jumped species from animal hosts into human beings. Pathogenic viruses increase the risk of chronic and fatal infections in patients whose very well-being are often dependent on the intravenous biologic and biotechnology products being administered. There also exist significant concerns about newly emerging and reemerging viruses such as West Nile, Ebola and Hantavirus. These concerns are further heightened by the terrorist events of 9/11, the subsequent anthrax attacks, and the potential for bioterrorism by pathogens such as Smallpox.
Pathogenic viruses can be broken down into two major categories – enveloped or lipid-encased viruses such as HIV and influenza, and nonenveloped or protein-encased viruses such as polio and hepatitis A. There is currently no commercially available process for the inactivation of nonenveloped viruses in human plasma and blood products.

Aphios' virus inactivation process is capable of inactivating both enveloped and nonenveloped viruses. The process utilizes supercritical, critical or near-critical fluids with or without cosolvents (SuperFluids™). These SuperFluids are normally gases which, when compressed, exhibit enhanced solvation, penetration and expansion properties. Aphios utilizes these fluids to permeate and inflate the virus particles. The overfilled particles are then decompressed and, as a result of rapid phase conversion and expansion, rupture at their weakest points. Like a scuba diver rising faster than the bubbles he or she generates, the viruses are given the "bends" and are rendered inactive.

Aphios' virus inactivation process 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.

Aphios' virus inactivation process can be applied to immunoglobulins and wound-healing biotherapeutics, human plasma used for blood transfusions, bone graft materials and other implantables, heat-labile and sensitive medical instrumentation, xenotransplantation products, animal sera used in the biotechnology industry, and recombinant therapeutics from mammalian cell culture and transgenic animals where a virus inactivation step is essential for the manufacture of safe products. The process can also be utilized for pathogen decontamination.

Research leading to the development of this technology was funded, in part, 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).

Aphios Corporation is a biopharmaceutical company that is developing enhanced natural therapeutics for health maintenance and the treatment of human diseases with a focus on infectious diseases, cancer including quality-of-life issues and certain CNS disorders.