Aphios
Awarded SBIR Grant from FDA For Development of a Virus Inactivation
Medical Device
December
19, 2000
— Aphios
Corporation has been awarded an SBIR grant from the Office
of Orphan Products Development of the Food and Drug Administration
(FDA). The grant is for the development of a medical device
to be utilized for reliable routine inactivation of different
HIV strains that may become associated with medical devices.
Medical
devices include any “instrument, apparatus, implement,
machine, contrivance, implant, in vitro reagent or
other similar or related article . . . intended for use
in the diagnosis of disease or other condition, or in the
cure, mitigation, treatment or prevention of disease . .
. or intended to affect the structure or any function of
the body . . . which does not achieve any of its principal
intended purposes through chemical action within or on the
body . . . and which is not dependent upon being metabolized
for achievement of any of its principal intended purposes.”
Devices
are regulated under Section 201 (h) of the Food, Drug and
Cosmetic Act, as amended by the Medical Device Amendments
of 1976 and the Safe Medical Device Act of 1990. There is
a need to develop a device for reliable routine inactivation
of different HIV strains associated with medical devices.
Such a device may fall into the Orphan Products category
(i.e. one affecting fewer than 200,000 people in the United
States) of the Food and Drug Administration (FDA).
Aphios
will develop a virus inactivation medical device by utilizing
a rapid and generally applicable virus inactivation technique
for both enveloped and non-enveloped viruses based on supercritical
and near-critical fluids (SuperFluids™) technology.
SuperFluids™ are normally gases which, when compressed,
exhibit enhanced solvation, penetration and explosive decompression
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,
rupture at their weakest points. The SuperFluids™ CFI
(critical fluid inactivation) process inactivates enveloped
viruses by a lipid solubilization mechanism and non-enveloped
viruses surrounded by a tough protein capsid through
the physical disruption of viral particles while
preserving biological activity and integrity of the treated
product.
Aphios’
specific aims and milestones are as follows: (1) establish
SuperFluids™ CFI conditions to inactivate > 6
logs of HIV-1 (greater than one million particles of HIV-1
per milliliter); (2) design a CFI virus inactivation
device for medical devices; and (3) evaluate technical and
economic feasibility of the CFI device versus alternate
strategies. The problem of virus inactivation is such a
serious issue that many possible methods of inactivation
should be considered. Aphios’ proprietary method has
many attractive features, the complete removal of solvents
being one strong component of this process.
Research
leading to the development of this technology was partially
funded by Small Business Innovative Research (SBIR) grants
from the National Science Foundation and a prestigious $2
million Advance Technology Program (ATP) grant from the
National Institute of Standards and Testing, Department
of Commerce. Aphios Corporation is a biopharmaceutical technology
and product company with a focus on developing research
tools and industrial processes for the improved discovery,
manufacturing, delivery and safety of naturally derived
and genetically engineered therapeutics for the treatment
of cancer, AIDS, and other infectious diseases in a cost-effective
manner.
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