Aphios
Granted Japanese Patent for Inactivating Viruses and Other
Pathogens in Biologics and Human Plasma
April
07, 2009
— 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),
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). 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.
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