Woburn, Mass. – November 06, 2019 − Aphios Corporation today announced that it has been awarded a Phase II Small Business Innovative Research (SBIR) grant from the National Heart Lung and Blood Institute (NHLBI), National Institutes of Health (NIH) to develop a generally-applicable virus and pathogen inactivation technology, CFI™, for the manufacturing of virus-free human plasma, plasma products such as immunoglobulins, recombinant biologics such as monoclonal antibodies and viral vaccines.
Biological products, immunoglobulins and human plasma and 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.
According to Dr. Trevor P. Castor, Principal Investigator, “Aphios’ critical fluid inactivation (CFI™) 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. 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 units and biologics. Although CFI is capable of inactivating wide classes of viruses, bacteria and parasites, it has negligible negative impact on biological integrity and potency of CFI-treated plasma units and biologics.”
Dr. Castor continues, “We have developed, tested and validated this process using continuous-flow laminar flow devices, and now plan to scale this technology down for processing individual units of plasma. The potential impact of a generally-applicable physical technology for inactivating viruses and emerging pathogens in plasma units with high retention of biological activity will be very significant. This technology will be very impactful to the clearance of viruses from units of human plasma in developing countries and hot zones such as those caused by the recent Ebola outbreak in western Africa.”
About Aphios Corporation:
Aphios Corporation (www.aphios.com) is a clinical-stage, emerging growth biotechnology company developing green enabling technology platforms for improving drug discovery and manufacturing, nanotechnology drug delivery and pathogenic drug safety. Based on these enabling technology platforms, we are developing enhanced therapeutics for health maintenance and disease prevention, and the treatment of cancers and supportive care such as CINV, infectious diseases such as HIV, and nervous system disorders such as Alzheimer’s Disease, Multiple Sclerosis, Pain and Opioid Addiction.
This research and development is being funded by Phase II SBIR Grant No. 4R44HL137605-02 from the National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health (NIH). The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of NHLBI and the NIH.
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