Universal Plasma Generator for Selective Removal of Anti-A and Anti-B Antibodies from Donor Plasma

Traumatic injury accounts for 14.2% of all fatalities. Clinical management of trauma often requires massive plasma transfusions. However, in critical combat casualty care or in civilian emergency trauma care, plasma of compatible blood group may not be readily available. Transfusion with incompatible plasma may result in potentially fatal hemagglutination in the recipient. Typeless or universal plasma i.e. plasma without anti-A/B antibodies can be safely transfused into any recipient without risk of hemagglutination. Lynntech and its STTR consortium have demonstrated very strong proof-of-concept for a novel universal plasma generator device in the preceding Phase I effort. Our device has been shown to selectively remove only anti-A/B antibodies from actual human plasma samples without co-depleting coagulation factors or total protein, thus making the resultant universal plasma safe to transfuse into patients of any blood type. Our device can be integrated into existing plasmapheresis instruments and also function standalone to process fresh frozen plasma thereby fulfilling the critical need for always-on-hand typeless plasma for safe transfusions. This proposed Phase II aims to optimize our approach and demonstrate scaled up production of universal plasma with our device to considerably improve the TRL and position the technology for FDA clearance and commercialization in future phases.