Microcapillary Quartz Sensors for Screening Injectability of High Concentration Protein Formulations

The main focus of this SBIR Phase II project is to develop a prototype instrument and test cartridges for injectability pre-screening of high concentration protein formulations (HCFs). HCFs are non-Newtonian fluids with shear-thinning behavior and they are formulated to be administered by subcutaneous or muscular injections. The injectability and manufacturability of HCFs depend on the viscosity behavior over a very wide range of shear-rates. In Phase I, QATCH demonstrated the feasibility of wide shear-rateviscosity measurements by its proprietary microcapillary quartz technology. In Phase II, QATCH will determine the 1) Sensor design for wafer-scale productions, 2) Processing steps for deployability of the sensors, 3) Prototype instrument firmware and software, and 4) Linearity and accuracy of the viscosity measurements on a wide range of solutions. The finalized prototype will be tested by external partners and be ready to be deployed to industry experts.