SBIR/STTR Phase II: Development of Integrated Fluid/Solid/Bio-Kinetic Simulation Software for the Characterization of Microsphere-based Bio-analytic Systems

This Small Business Innovation Research (SBIR) Phase II project will develop and customize advanced simulation software for the design and optimization of microsphere and cell-based assays. Current assay design by trial and error is slow, unreliable, expensive, and a bottleneck for multiplexed, high-throughput analysis. Prior Phase I research has successfully established a first-ever, truly integrated (buffer flow, resolved microsphere motion and surface biochemistry) assay design and analysis tool. The objective of the Phase II effort is to further develop the initial models demonstrated in the Phase I effort into a comprehensive, generalized design environment. A suite of bead-surface biochemistry models (enzyme kinetics, multi-step reactions) and including user specifiable surface reaction mechanisms will be developed and fully integrated. In seeking to expand the application to cell-based assays, models for the motion and capture of deformable cells will be created, and detailed flow visualization experiments tracking bead and cell motion as well as assay endpoints in microfluidic channels will be conducted to guide and validate these models. The value of the developed simulation tool will be demonstrated in the proof-of-concept design of a novel microfluidic, cell-based H-filter assay for red-blood cell based aminothiols. The commercial applications of this project will be in the biotechnology and bioassay design markets. Miniaturized, multiplexed, high-throughput, fast, efficient and sensitive assays are a pre-requisite to translating the wealth of data from the human genome and combinatorial libraries into effective therapeutics. The developed software product will enable rational, computer-based design of these bioassays.