Microcapillary Quartz Sensors for Screening Injectability of High Concentration Protein Formulations

The objective of this SBIR Phase I proposal is to determine the feasibility of viscosity characterization of high concentration protein formulations (HCF) by QATCH’s microcapillary quartz technology. HCFs are non-Newtonian fluids with shear-thinning behavior and they are administered to patients by subcutaneous or muscular injections. The injectability of HCFs depends on the viscosity at high-shear-rates (usually over 100,000 1/s). QATCH’s proposed technology implements a microfluidic capillary viscometer on a quartz resonator. This unique combination can interrogate low shear-rate regimes while also measuring the thickness-shear mode resonances of the quartz resonator, which observe viscosity values over 1,000,000 1/s. As a result, the viscosity of HCFs can be characterized over a wide range of shear-rates with very small fluid volumes. In preliminary studies, QATCH had demonstrated that microfluidic quartz can measure viscosity at high-shear-rates experimentally and had modeled the response of the microfluidic quartz resonators to capillary filling of shear-thinning fluids. To accomplish the objective of this SBIR proposal, QATCH will test the low and high-shear rate measurement capability of the system and then calculate the required injection forces for well studied formulations.