Production of GLP ErythroMer for IND Enabling Animal Studies

ErythroMer (EM) is a universal, artificial, red blood cell (RBC) substitute designed to mimic the oxygen-carrying capabilities of native RBCs. It uses purified hemoglobin encapsulated in a lipid polymer nanoparticle shell and is supplied in a dry powder form for easy reconstitution with a shelf life of two years. The manufacturing process involves detailed processes for extracting and purifying hemoglobin from expired human blood units including lipid extraction, ultra-centrifugation, and size exclusion tangential flow filtration. Incorporation of multiple safety measures, including donor selection, viral inactivation, and the use of filters for virus removal. Studies on rabbits demonstrated that ErythroMer effectively restores normal hemodynamics and oxygen delivery after acute hemorrhage with minimal acute toxicity and adverse events. The product addresses a critical need for effective blood substitutes in emergency medical care, thereby enhancing trauma care and potentially saving lives. ErythroMer targets both military and civilian markets, as well as veterinary medicine for military and civilian working dogs. For this project, KaloCyte will work in collaboration with Southwest Research Institute (SwRI) to scale-up the EM manufacturing process and produce a pilot GLP batch. The production process involves filtration, mixing with additives, extrusion, clarification, and filling under inert gas conditions. This production method is scalable, with plans to replace high-pressure extruders with a multi-online liposome extruder system for continuous liposome extrusion. The outcome of this project will be a scaled up manufacturing process and delivery of a batch of ErythroMer for use in GLP IND-enabling toxicity studies.