HTS/CryoStor-Liver- Is Viability Linked to Function?

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DESCRIPTION (provided by applicant): BioLife Solutions Inc is a Biological Packaging company dedicated to developing improved solutions for hypothermic storage (4 to 8C) and cryopreservation (-196C) of human cells and tissues. The HTS platform consists of HTS-BASE, HTS-DCC, HTS-FRS and custom hypothermic preservation solutions currently being designed for clients in the Regenerative Medicine market. BioLife's CryoStor cryopreservation solution platform is designed for storage of cells and tissues in liquid nitrogen. BioLife's solutions are designed by f_ understanding the molecular details of cell death cascades that can be activated as a consequence of hypothermic storage or cryopreservation. Once understood, solution formulation is altered such that these cell death processes are inhibited. As a consequence of this rational, molecular approach, BioLife's HTSFRS is superior to LIW Solution (ViaSpan), the solution currently used for hypothermic preservation of most human organs for transplantation. Similarly, BioLife's serum-free CryoStor series may be better for cryopreservation than the current ATCC industry protocol. BioLife's solutions are now FDA-approved as part of BioHea_'s IND in cellular cardiomyoplasty. This success captured the interest of Tissue Transformation Technologies (T3), which plans cell therapy applications with primary human hepatocytes to treat liver disease. BioLife developed a prototype HTS-LIVER platform that preserves the viability of a human hepatoma cell line several-fold longer than UW. The development of CryoStor-BASE suggests that the development of a CryoStor-LIVER platform is also probable. The Specific Aims of this proposal are to determine if: (1) HTS-LIVER works equally as well with primary human hepatocytes as it does with a human hepatoma cell line; (2) viability and function of hypothermically preserved primary human hepatocytes are linked; (3) the same modifications to HTS-BASE that generated HTS-LIVER can result in the development of CryoStor-LIVER; (4) modifications to HTS-LIVER or CryoStor-LIVER can improve their abilities to protect cell viability and function during preservation. Development of HTS-LIVER and CryoStor-LIVER are critical to support T3's human hepatocyte cell therapy applications in Regenerative Medicine. In addition, development of improved hypothermic and cryogenic preservation platforms will immediately benefit T3 by providing a means to reach larger national and international research markets with primary human hepatocytes.