SBIR Phase I: High-throughput injectability screening of high concentration protein formulations by multiplexed microfluidic quartz resonators

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The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project advances a new type of drug delivery. Protein-based drugs (biologics) have become more popular due to their high specificity of activity and generally low level of side effects. Biologics treat many conditions, impact lives of millions of patients, and have a global revenue of over $100 B. Patients prefer and comply with injectable versions of biologics because injections are rapid and make home-administration possible, unlike IV infusions that require clinic visits lasting several hours. However, the development and utility of many biologics is hampered by their inability to be used via injections because they are thick liquids. The technology developed in this project will act as an early-stage screening to determined the suitability of potential drug formulation for injection, enabling delivery of new drugs.This SBIR Phase I project will increase the number of injectable protein-based therapeutics by providing early screening of protein formulation viscosity. Viscosity measurements early in formulation development are currently not possible because the existing viscometers require high material volumes. Therefore, injectability of new protein-based formulations cannot be tested until significant amounts of material are developed, typically at late stages of preclinical research. This project will create a high-throughput viscometer that requires only drops for each test, for formulation optimization; it will determine the feasibility of multiplexing microfluidic quartz sensors on the same substrate to achieve simultaneous viscosity measurements. Specifically, in this project, 1) the electronics for the multiplexed sensors will be developed, 2) the multiplexed sensors will be designed using analytical and finite element models, and 3) these designs will be executed by microfabrication. Finally, the multiplexed microfluidic quartz sensors will be tested by analyzing relevant formulations simultaneously.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.