APPARATUS AND METHOD FOR INACTIVATIVING VIRUSES AND PATHOGENS IN CONVALESCENT PLASMA UNITS FROM RECOVERED COVID-19 PATIENTS

摘要

The novel coronavirus COVID-19 has caused a worldwide pandemic of enormous proportions resulting in significant levels of morbidity and mortality, tremendous pressures on the healthcare system, personal freedoms and society, and an unprecedented impact on the economies of the United States and the world. There are still significant unknowns about this very contagious and deadly virus, and these unknowns are coupled with no natural immunity. A promising therapeutic strategy is the utilization/transfusion of convalescent plasma from recovered COVID-19 patients. There are, however, risks involved in such transfusions from residual virus and other adventitious viruses and bacteria. These risks can be minimized by the pathogen clearance of convalescent plasma units in a hospital setting. There is an immediate need for the rapid pathogen inactivation/clearance of convalescent plasma units from recovered COVID-19 patients.;The present invention is a physical pathogen reduction and inactivation apparatus and method for controlling or eliminating transfusion-transmittable infections in convalescent plasma from recovered COVID-19 donors. The invention inactivates both nonenveloped and enveloped viruses as well as pathogenic bacteria and parasites in units of human plasma, while retaining the potency of natural biologically-active proteinaceous products in the pathogen-reduced plasma. The invention uses critical, near-critical or supercritical fluids for viral and pathogen reduction of units of donor blood plasma in blood bags. The apparatus is in the form of a transportable mobile unit, where it can be used in hospitals, blood banks, and medical facilities.