CFI™ Pathogen Inactivation Technology скачать в хорошем качестве

CFI™ Pathogen Inactivation Technology

Aphios International is developing a pathogen reduction technology platform, CFI™ for human plasma, plasma products, immunoglobulins, recombinant biologics, monoclonal antibodies and medical devices such as PPEs, N95 masks and single use devices. Human plasma, biological products and medical devices are at significant risks from virus and bacterial pathogens. Both the FDA and EMA have in place rigorous guidelines for pathogen safety. A number of approaches have been employed for the reduction of pathogens in human plasma, therapeutic proteins derived from human plasma, recombinant biologics and medical devices. 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 and devices that they are designed to protect. Currently, there is no commercially available, FDA-approved technology for the inactivation of non-enveloped viruses in 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 infectivity and replication 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.