Aphios International is developing a generally applicable pathogen inactivation technology platform, CFI™, for the manufacturing of virus-free human plasma, plasma products such as immunoglobulins, recombinant biologics such as monoclonal antibodies and viral vaccines.
Human plasma and biological products are at significant risks from viruses. Both the US FDA and EMA have in place rigorous guidelines for viral safety. A number of approaches have been employed for the inactivation or removal of viruses in human plasma, harnessing therapeutic proteins derived from human plasma and preparation of recombinant biologics. Current approaches are not always effective against a wide spectrum of human and animal viruses, sometimes encumbered by process-specific deficiencies, and often result in denaturation of the biologics that they are designed to protect. Currently, there is no commercially available, FDA-approved technology for the inactivation of non-enveloped viruses in units of and/or pooled human plasma and biologics, and only one method has been approved for units of plasma that inactivates some but not all known non-enveloped viruses
CFI™ pathogen inactivation technology works, in part, by first permeating and inflating virus particles with the selected Superfluids™ under pressure. The overfilled particles are then quickly decompressed, and the dense-phase fluid rapidly changes into a gaseous state rupturing the virus particles at their weakest points — very much like the embolic disruption of the ear drums of a scuba diver who surfaces too rapidly. The disruption of viral structure and release of nucleic acids prevent replication and infectivity of the CFI treated viral particle.
CFI™ technology, which inactivates both enveloped and non-enveloped viruses, is applicable to both pooled human plasma, units of plasma and biologics. The potential impact of a generally applicable physical technology for inactivating both enveloped and non-enveloped viruses and emerging pathogens with high retention of biological activity is very significant.