Woburn, MA — 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.