SBIR Phase I: Vertical Perfusion System for Cell Culture and Monitoring

This Small Business Innovation Research (SBIR) Phase I project will attempt to show feasibility of a Vertical Perfusion Cartridge system to improve in vitro studies of diverse cell types, including insulin-producing Islets of Langerhans. Basic and applied cell physiology research could be advanced with the development of the proposed perfusion system. The aim is to develop a convenient, mass produced and easily used perfusion column cartridge that contains four to sixteen chambers. Modular construction of the assembly facilitates loading of the islets, controlling and maintain perfusion and performing real-time measurement of oxygen consumption rate (OCR), cytochrome-c oxidative state, NADH and other molecules via absorption/fluorescence spectroscopy in response to physiological perturbations. The proposed design will allow convenient sterilization, optionally reusable or disposable components, built-in oxygen sensors and associated instrumentation for real-time monitoring and recording of data. During Phase I, the plan is to design, build and evaluate one or more cartridge systems, using non-living cell-replicates and using live islets. Three significant commercial markets for the proposed technology are related to islet transplantation, basic islet research, and drug discovery, multi-billion dollar industries that pay a premium for methods capable of reducing development and operational risks. Two recent publications estimated the total real cost of islet transplantation procedures at $100,000 to $150,000 per patient, though the cost will fall over time as the procedures are refined. Nonetheless devices that either identify viable islets or assist in the development of such methods, or that speed research into alternative transplant methods, such as encapsulation, would quickly pay for themselves in cost savings. Applications related to islets include basic research into physiology and function, development and validation of drugs targeting islets, and assessment of islet viability prior to transplantation. Researchers who work on basic function and biology of islets will find this system useful because it enables the examination of multiple sets of islets simultaneously, thus improving statistical significance of their findings.