SBIR-STTR Award

Improved methods for frozen storage of glycerolized red blood cells (RBCs) are needed both tomeet military and civilian needs in periods of high demand. Existing deglycerolization ssytems are labor intensive and considered "open" systems resulting in a maximum storage of 24hrs following washing. The washing of cells with flat sheet membrane filters has been proven effective by the Advanced Haemotechnologies PlateletPlus (TM) Autotransfusion System. They system saves RBCs and reomves >90% of plasma contaminants. If awarded, Phase I activities will include design, construction and testing of three different filter device configurations. They will include multistage continuous flow, single state whole unit, and single stage multibatch devices. Prior to testing the prototype devices, PlateletPlus (TM) filters assembled with various candidate membranes will be tested to select the optimum pore size for deglycerolization. A PlateletPlus (TM) console with modified software will control all filter devices. Tests will be performed using packaged RBCs and frozen glycerolized blood. The major goals of Phase I testing will be to demonstrate that one or more device configurations meet the following requirements: 1. Total processing time <25 minutes 2. Final Hematocrit -- approximately 40% 3. Residual glycerol <1%W/V

Keywords:
Erythrocyte Cryopreservation Membrane Deglycerolization Red Blood Cell Glycerol Filtration

Improved methods for frozen storage of glycerolized red blood cells (RBCs) are needed both to meet military and civilian needs in periods of high demand. Existing deglycerolization systems are labor intensive and considered "open" systems resulting in a maximum storage of 24 hours following washing. The washing of blood cells with flat sheet membrane filters has been proven effective by the Advanced Haemotechnologies PlateletPlus TM Autotransfusion System. AHT completed Phase I development of a novel membrane device which is capable of washing a unit of frozen-thawed RBCs in less than 20 minutes, with a residual glycerol level of less than 1%, and a final hematocrit of approximately 40%. Phase II development will include: optimization of the disposable to yield higher hematrocrits, low glycerol residuals and low supernatant hemoglobin levels; design and prototyping a console with evaluation by the NBRL of performance; and preliminary evaluation of a modified filter for washing frozen/thawed platelets. Sucessful completion of the Phase II development will lead to a closed, sterile washing system for thawed blood and should allow for extended storage thawed RBC products.

Keywords:
Erythrocyte Cryopreservation Membrane Filtration Deglycerolization Red Blood Cell Glycerol