This Small Business Technology Transfer Phase I project will generate a new nanoparticle characterization system with the ability to assess the size, length-to-width ratio, zeta potential, and concentration of solution-based nanoparticle (or molecular) samples with state-of-the-art accuracy, precision, and resolution, all on a single platform. The primary need for new nanoparticle characterization instrumentation is driven by the increasing utility and benefit of nanoparticles in healthcare and medicine, including nanoparticle drug delivery, nanoscale particle/molecule drugs and therapies, and nanoparticle-based imaging and diagnostics agents. The prototype system developed under this program will be targeted toward the general nanoparticle characterization market, presently estimated at ~$500M, which includes applications in the pharmaceutical and biomedical industries, nanoparticle manufacturing, R&D, and academic research. The developed system will not only improve solution-based nanoparticle characterization, but streamline characterization processes and provide new insights with regard to sample characterization, optimization, and utilization within the nanoparticle field.<br/><br/>The intellectual merit of this project lies in the development of a completely new and innovative particle characterization system for which there is no equivalent, capable of automated, high-resolution, solution-based particle assessments at the single-molecule level. The developed system will enable the ability to quickly characterize a large number (hundreds to thousands) of particles/molecules in solution in order to assess the distribution within the sample. These goals will be reached by developing, building, and validating a complete and fully functioning alpha-prototype system and then demonstrating the functionality and utility of the new system by characterizing solution-based particle- and molecule-containing samples that otherwise cannot be characterized with high resolution. Upon completing this program, an entirely new nanoparticle characterization instrument will be developed and validated that is ready for initial introductions into the nanoparticle field via industrial and academic communities.