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.
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.
