Woburn, Mass. – February 01, 2023 – Aphios today announced that it has been granted a registered trademark CFI® on January 31, 2023 for the pathogen reduction of human plasma products such as immunoglobulins, biologics such as monoclonal antibodies and viral vaccines. CFI® is an acronym for Critical Fluid Inactivation (the registration mark is 6,969,539).
Biological products, immunoglobulins and human plasma are at significant risks from viruses and other pathogens. Both the US FDA and its European equivalent, the EMA, have in place rigorous guidelines for pathogen safety. A number of approaches have been employed for the pathogen reduction of human plasma, therapeutic proteins derived from human plasma and recombinant biologics. Current approaches are not always effective against a wide spectrum of human and animal pathogens, sometimes encumbered by process-specific deficiencies, and often result in denaturation of the biologics that they are designed to protect. Currently, there are not any commercially available, FDA-approved technologies for the pathogen reduction or inactivation of nonenveloped 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 nonenveloped viruses.
According to Dr. Trevor P. Castor, President and CEO, Aphios, “CFI® works, in part, by first permeating and inflating pathogens with the selected critical fluid under pressure like blowing up a balloon or bubble. The overfilled particles are then quickly decompressed, and the dense-phase critical fluid rapidly changes into a gaseous state rupturing the pathogens 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 the pathogen structure and release of nucleic acids prevent replication and infectivity of the CFI® treated pathogen particle. This purely physical technique does not involve the use of heat, chemicals and/or irradiation, each of which has significant drawbacks in the pathogen clearance of human plasma and biologics. Although CFI® is capable of inactivating wide classes of pathogens – viruses, bacteria and parasites, it has negligible negative impact on biological integrity and potency of CFI®-treated human plasma and biologics.”
Dr. Castor continues, “We have developed, tested and validated CFI®-using continuous-flow laminar flow devices, and have scaled this technology down for processing individual units of biologics. The potential impact of a generally-applicable physical technology for reducing pathogens and emerging viruses in plasma units with high retention of biological activity is very significant considering the tremendous healthcare, social and financial impact of the COVID-19 pandemic and the potential for future pandemics. CFI®-will be very impactful to the reduction of pathogens from biologics and human plasma in developing countries and hot zones such as those caused by the recent Ebola outbreak in western Africa, both positively impacting the local and worldwide populations and economies.”
About Aphios Corporation:
Aphios (www.aphios.com) is a clinical stage, green biotechnology company developing enabling technology platforms to improve drug discovery and manufacturing, nanotechnology drug delivery and pathogenic safety. Based on these platforms, Aphios is developing enhanced therapeutics to prevent disease, maintain health, improve quality-of-life and treat chronic diseases including cancers and supportive care, infectious diseases such as HIV/AIDS, influenza and COVID-19, and central and peripheral nervous system disorders in an environmentally sustainable manner.
Research reported in this press release was supported by the National Institute Of Allergy And Infectious Diseases of the National Institutes of Health under Award Number R43AI165352. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.