SBIR/STTR Award attributes
Over 2.7 million units of plasma are transfused annually in the United States mainly to treat trauma, shock, burn injury, and emergency surgery. Plasma from AB individuals, often referred to as universal plasma, is in high demand for both military and civilian emergency transfusions as it does not contain anti-A and anti-B antibodies that could induce fatal hemolytic reactions as a result of their binding to the recipient's red blood cells. Supplies are often insufficient to meet demand however as only 4% of the overall donor population is type AB. Therefore, there is a large potential market for a simple cost-effective product that can quickly remove anti-A and anti-B blood group antibodies (BGA) from single donor or pooled plasma units to generate a sufficient inventory of universal plasma and potentially alleviate the need to store type-specific plasma altogether. An expanded supply of universal plasma will simplify storage and distribution logistics for civilian and military blood banks allowing them to meet widespread demand without straining donor resources. During Phase II studies, CytoSorbents developed a novel device called HemoDefend-BGA Adsorber that removes >99% of anti-A and anti-B antibodies from plasma, while maintaining coagulation activity. Moreover, the HemoDefend-BGA device works just as well on fresh whole blood (FWB), sparing beneficial substances such as coagulation factors, RBCs and platelets to alleviate the reliance on low titer O whole blood (LTOWB) donors for emergency FWB transfusions. While substantial cost savings in the procurement, documentation, testing and the simpler storage and distribution logistics of universal blood products will significantly offset the cost of this technology, cost constraints within the blood banking community dictate that costs are a major consideration to adoption of new technologies. Therefore, this proposal will focus on optimizing manufacturing methods to achieve a cost-effective product for high volume production. The refined device will be validated for BGA reduction with minimal effect on coagulation and hemostatic activities in bench top studies with plasma and whole blood. The HemoDefend-BGA adsorber is a potentially paradigm-shifting technology that can be utilized during plasma collection and processing to generate an inventory of single donor or pooled universal plasma units potentially alleviating the need to store type-specific plasma altogether. In addition, its use at the time of blood collection would provide not only the option of LTOWB and low titer plasma but low titer RBCs and platelets as well, minimizing the unpredictable risk of hemolytic transfusion reactions from the residual plasma in all blood components, increasing the safety of the blood supply.
