Ultrasonic Cryoconcentration of Human Plasma

说明书（由申请人提供）：血浆对直接输血和药品生产至关重要。大多数等离子体在使用之前是冷冻的，然而，在冷冻过程中，不可避免地存在等离子体溶质不受控制的冷冻浓缩。本项目的目标只是控制这一普遍接受的过程。首先，应用超声波来增强冷却等离子体内冰晶的形成和生长。因为蛋白质没有被冷冻，所以它们不会受到机械冻害。接下来，盐的浓度保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造成的损害更小，正如用低温沉淀进行的初步测试所显示的那样。提出的大部分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随时间和应用超声强度的变化，超过多个无菌处理袋的几何形状。与传统产品相比，初步测试表明，由此产生的冷冻浓缩物在运输和储存方面更便宜，更容易检测病原体，而且它们的冷冻沉淀产量几乎是传统产品的两倍。它们的冷冻、解冻、冻干和分馏速度也快了几个数量级。

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.