SBIR-STTR Award

The main objective of this proposal is to develop and deliver a high density continuous perfusion cell microarray to enable high throughput and high quality cell-based screening for the pharmaceutical and biotechnology industry. More specifically, the 6-month Phase I project will focus on developing the core microfluidic cell microarray for high throughput in vitro toxicity screening of human hypatocyte cell lines for better prediction of drug toxicity at an early stage of the drug discovery processes. Taking advantage of the state-of-the-art polymer and semiconductor manufacturing processes, we will create a rigid and robust microfluidic template to reliably copy thousands of replicates. With our demonstrated expertise in microfabrication and the proprietary high aspect ratio soft lithography technology, we will make robust high throughput toxicity analysis readily available in the market. The primary targets of this project are to develop reliable and high yield manufacturing process for high aspect ratio microfluidic devices and to deliver a high density cell microreactor array with binary combinatorial culture and assay functions.

The main objective of the Phase II proposal is to further develop the microfluidic cell culture array for high quality cell-based life science applications in the pharmaceutical and biotechnology industry. This will focus on predictive hepatotoxicity screening, which has been included as one of the Critical Path Initiatives by the FDA to provide additional pre-clinical drug screening tools other than animal models. The value of this proposition is to improve prediction of drug toxicity during the expensive and time consuming human clinical trials. The completion of the Phase II project will enable us to start beta testing with pharmaceutical companies on drug compounds that passed animal studies yet still caused liver injuries during clinical trials. If CellASIC's product is successful, a 10% improvement in predicting these clinical trial failures could reduce the average cost of drug development by nearly $100 million, not to mention saving people's lives in clinical trials and reducing the amount of animal studies. The Phase II proposal is to continue the awarded Phase I project (1R43CA117178-01A1) under program announcement PA-04-161 "Manufacturing Processes of Medical, Dental, and Biological Technologies", more specifically, to the commercialization of a microfluidic cell culture array to predict drug compound toxicity in clinical trials using human hepatocytes. The successful completion of the project will provide the pharmaceutical and biotechnology industry a better and more cost-effective platform on predictive toxicology and DMPK (drug metabolism and pharmacokinetics) profiling