Ultrasonic Cryoconcentration of Human Plasma

描述(申请人提供)：血浆对于直接输血和药品生产至关重要。大多数血浆在使用之前被冷冻，然而，在冷冻过程中，血浆溶质的冷冻浓缩是不可避免的，不受控制的。这个项目的目标很简单，就是控制这个普遍接受的过程。首先，应用超声波来促进冰晶在冷却的等离子体中的形成和生长。因为蛋白质因此不会被冻结，所以它们不会受到机械性的冷冻损伤。接下来，将盐浓度维持在不会使蛋白质变性的水平。与传统系统相比，这项新技术对血浆蛋白质造成的损害更小，这一点通过冷沉淀物的初步测试表明。大部分拟议的实验工作都致力于确定这项新技术的最佳操作条件。最感兴趣的参数是蛋白质质量和产量与时间和施加的超声波强度之间的关系，在多种无菌处理袋几何形状上。与传统产品相比，初步测试表明，由此产生的冷冻浓缩物运输和储存成本更低，更容易检测病原体，而且冷沉淀物的产量几乎是传统产品的两倍。它们在冷冻、解冻、冷冻干燥和分离方面也快了几个数量级。

DESCRIPTION (provided by applicant): 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.