Aphios
Granted US Patent for Inactivating Viruses and Other Pathogens
in Human Plasma and Blood Products
November
04, 2002
— Aphios
Corporation was 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 re-emerging 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/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 dive rising faster that the
bubbles he/she generates, the viruses are given the “bends”
and become 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 and necessary 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),
U.S. 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 (www.aphios.com) 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.
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