Aphios
Corporation granted European Patent for Inactivating Viruses
September
13, 2000
— Aphios
Corporation was granted European Patent No. 0629135 on July
26, 2000. The patent is entitled “Viral Inactivation Method,”
and is available for licensing.
Aphios’ virus inactivation method is based on
advanced liquid-liquid technology using supercritical, critical
or near-critical fluids with/without cosolvents (SuperFluids™)
for the gentle and rapid inactivation of both non-enveloped
and enveloped viruses. SuperFluids™ are normally
gases which, when compressed, exhibit enhanced solvation,
penetration and expansion properties. SuperFluids™
are used 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.
Inactivation
of pathogenic viruses is a major healthcare concern. Viruses
of concern include the enveloped HIV, the non-enveloped
hepatitis A virus, and new “hot zone” viruses
which may have jumped species from animal hosts into human
beings as a result of rain forest disruptions or which are
being created from evolutionary mutations in hospital waiting
rooms. 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.
Unlike
certain commercially-available virus inactivation techniques
which only inactivate enveloped viruses and may not be able
to inactivate certain “hot zone” viruses, Aphios’
SuperFluids™ CFI (critical fluid inactivation) process
is generally applicable to all classes of viruses. Unlike
currently-available virus inactivation techniques that utilize
organic solvents, heat and/or chemicals, the CFI
process is purely physical. The CFI process can
reduce the viral load of most enveloped and non-enveloped
viruses by more than 6 logs (99.9999 %) in times less than
20 seconds. Interestingly, the process is very gentle to
therapeutic proteins and enzymes which retain structural
and biological integrity. Products are left without traces
of denaturing solvents or potentially mutagenic chemicals
being utilized in current virus inactivation technologies.
CFI is amenable to batch or continuous-flow operations,
is readily scalable and enjoys economies of scale.
The SuperFluids™ CFI 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, xeno-transplantation
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.
Research
leading to the development of this technology was in part
funded by Small Business Innovative Research (SBIR) grants
from the National Institutes of Health, the National Science
Foundation, and a prestigious $2 million Advance Technology
Program (ATP) grant from the National Institute of Standards
and Testing, U.S. Department of Commerce. Aphios is a privately
held biopharmaceutical company specializing in drug discovery
and in the manufacturing, delivery and safety of naturally
derived and genetically engineered therapeutics for cancer,
CNS, AIDS and other infectious diseases. Aphios’ principal
research and manufacturing facilities are in Massachusetts
at 3-E Gill Street, Woburn, MA 01801, USA, tel.: (781)
932-6933, fax: (781) 932-6865, e-mail: aphios@aol.com
.
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