Plasma is of vital importance for direct transfusion and the manufacture of pharmaceuticals. Most plasma is frozen before such uses, however, during the freezing process, there is unavoidable, uncontrolled cryoconcentration of the plasma solutes The goal of this project is simply to control this universally accepted process. First, ultrasound is applied to enhance the formation and growth of ice crystals within the chilled plasma. Because the proteins are thus not frozen, they experience no mechanical freeze damage. Next, the salt concentrations are maintained at levels that do not denature the proteins. Compared to conventional systems, this new technology thus causes less damage to the plasma proteins, as shown by preliminary testing with cryoprecipitates. Most of the proposed experimental effort is devoted to determining the optimum operating conditions for this new technology. The parameters of greatest interest are the protein quality and yield versus time and applied ultrasonic intensity, over multiple sterile treatment bag geometries. Compared to conventional products, preliminary tests show that the resulting cryoconcentrates are cheaper to transport and store, they are easier to test for pathogens, and they have nearly twice the cryoprecipitate yield. They are also orders of magnitude faster to freeze, thaw, lyophilize and fractionate.
