Aphios
Corporation Presents "SuperFluids™ CFI Pathogen
Inactivation Technology for Biologics and Vaccines”
at CTSA
(Clinical Translational Science Awards, National Institutes
of Health) Industry Forum in Bethesda, Maryland
February
17, 2010
— Aphios®
Corporation is developing a physical pathogen inactivation
process for non-enveloped and enveloped viruses as well
as pathogenic bacteria and parasites in biologics such as
human plasma, plasma protein products and recombinant therapeutics.
The process utilizes supercritical and near-critical fluids
(SuperFluids™ or SFS). SuperFluids™ are normally
gases which, when compressed, exhibit enhanced solvation,
penetration and expansion properties. These gases are used
to permeate and inflate the virus and pathogen particles.
The overfilled particles are then decompressed and, as a
result of rapid phase conversion, rupture at their weakest
points.
Research to date
indicates that the SuperFluids™ CFI (critical fluid
inactivation) process inactivates both enveloped viruses
such as MuLV, VSV, TGE, BDVD, Sindbis and HIV and nonenveloped
viruses such as Polio, Adeno, Reo, Parvo and EMC while preserving
biological activity of the treated product. In a research
collaboration with the National Institute of Biological
Standards and Control (NIBSC), London, England, we demonstrated
that SuperFluids? CFI can inactivate more than 4 logs of
human Parvovirus B19 (one of the smallest and toughest viruses)
in human plasma in a two-stage CFI unit in less than 20
seconds. We have also demonstrated that SFS can disrupt
and inactivate microorganisms such as E. coli,
and thick-walled prokaryotes such as B. subtilis
and tough eukaryotes such as S. cerevisiae at viral
inactivation SFS conditions. CFI can be used with conventional
viral reduction methods such as SD and nanofiltration as
an orthogonal method of pathogen clearance.
A generally-applicable
physical technology for inactivating viruses and emerging
pathogens with high retention of biological activity will
help ensure a blood supply that is safe from emerging and
unknown pathogens as well as bioterrorism threats. In addition
to human plasma and human plasma proteins, the developed
technology will also be applicable to recombinant therapeutics,
monoclonal antibodies, transgenics and vaccines.
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