Aphios' virus inactivation method is based on advanced liquid-liquid technology using supercritical, critical or near-critical fluids with or 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, 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.
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, US 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.