ENHANCED THERMAL TRANSFER DEVICE FOR BIOPRESERVATION

保存细胞和组织的有效方法对于使用冷冻保存作为其生产过程的一部分的成熟和新兴公司至关重要。常规的冷冻和解冻装置具有低的热传递效率，这导致生物材料中的不均匀热处理，导致产品具有低的和不一致的细胞活力。开发一种在低温保存期间向样品和从样品提供快速、均匀的热传递的装置将允许公司严格控制热处理参数，从而能够开发一致的、高活力的低温保存过程。第一阶段STTR提案的主要目标是建立和测试流化床低温保存系统原型。此外，该提案将测试以下假设：使用流化床低温保存系统，多个生物样品的效率增加和均匀传热应增加总体产物细胞活力。将与传统的基于常规的控制速率冷冻和解冻系统进行比较。如果该装置显示出优于常规设备的上级，则这些研究将扩展到II期STTR提议，以扩大流化床系统的规模并将其应用于同种异体移植组织和工程化组织构造。拟议的商业应用：生物医学、组织工程和生物技术行业的快速和持续增长需要以较低成本生产更高产品的工艺。快速、均匀的传热过程对于高质量产品的存储至关重要，这些产品可能会影响目前美国医疗产品市场的50%。

Effective methods of preserving cells and tissues are essential for the established and emerging companies using cryopreservation as part of their production processes. Conventional freezing and thawing devices have low heat transfer efficiencies that cause non-uniform thermal processing in biological materials resulting in products with low and inconsistent cell viability. The development of an apparatus to provide, rapid, homogenous heat transfer to and from samples during cryopreservation would allow companies to tightly controlled thermal processing parameters enabling the development of consistent, high viability cryopreservation processes. The primary objective of this Phase I STTR proposal is to build and test a fluidized bed cryopreservation system prototype. Furthermore, this proposal will test the hypothesis that increased efficiency and homogenous heat transfer with multiple biological samples using a fluidized bed cryopreservation system should increase overall product cell viability. Comparisons with conventional convention-based control-rate freezing and thawing systems will be made. If this apparatus is shown to be superior to conventional equipment, these studies will e extended to a Phase II STTR proposal to both scale up and apply the fluidized bed system to allograft tissues and engineered tissue constructs. PROPOSED COMMERCIAL APPLICATIONS: The rapid and continued growth in the biomedical, tissue engineering and biotechnology industries requires processes that yield higher products at lower cost. Rapid, uniform heat transfer processes are essential for the storage of high quality products that may impact 50% of the current trillion dollar plus US Market for medical products.