DESCRIPTION (provided by applicant): Primorigen Biosciences will use Phase II SBIR funds to accelerate and expand the development of new regenerative medicine cell therapies by developing a novel high throughput, low cost protein quantification system for characterizing pancreatic 2 cell and islet cell differentiation. Primorigen successfully confirmed the technical feasibility of this proposal by achieving both major goals of the Phase I project, first demonstrating (and now routinely using) its proprietary Spots on Dots frameless microarray platform for high throughput antibody screening and characterization, and then demonstrating feasibility of developing a multiplexed protein quantitation assay for pancreatic beta cell differentiation by producing a prototype multiplexed assay with matched antibody pairs for quantifying two important markers of 2 cell differentiation (Nkx2.2 and MafB) and with 9 additional assays (Amylase 2B, FoxA2, GCK, HNF6, Isl1, NeuroD1, Neurog3, Pax4 and Pax6) in advanced stages of testing and development. In Phase II, Primorigen will complete the existing panel of assays for up to 11 markers of 2 cell differentiation (Phase I) and develop a new panel for identifying and characterizing mature islet cell populations, including 1, 2, 4, 5, and Pancreatic Polypeptide (PP) cell types. These combined tools will provide a more complete solution for tracking downstream development and maturation of pancreatic beta cells, and will be validated by obtaining independent corroboration of the performance and specificity of the assays. In addition, Primorigen will collaborate with a software developer to produce a software/flatbed scanner package that enables standardized analysis and reporting of data from assays run on the Spots on Dots platform in a rapid, 'one touch' format.