ENHANCED THERMAL TRANSFER DEVICE FOR BIOPRESERVATION

对于将冷冻保存作为其生产过程一部分的老牌和新兴公司来说，保存细胞和组织的有效方法是必不可少的。传统的冷冻和解冻设备具有较低的热效率，这会导致生物材料的热处理不均匀，从而导致产品的细胞活性低且不一致。开发一种在低温保存过程中向样品提供快速、均匀的热传递的设备，将使公司能够严格控制热处理参数，从而能够开发出一致的、高可行性的低温保存过程。这一第一阶段STTR提案的主要目标是建立和测试一个流态化低温保存系统原型。此外，这项提议将检验这样一种假设，即使用流态化低温保存系统提高效率和对多个生物样本进行均匀的热传递应该会提高整体产品细胞的活力。将与传统的基于控制速率的冻结和解冻系统进行比较。如果该设备被证明优于传统设备，这些研究将扩展到第二阶段STTR提案，扩大规模并将流态化系统应用于同种异体组织和工程化组织构建。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、统一的热传递过程对于高质量产品的储存至关重要，这些产品可能会影响目前万亿美元以上的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.