Qatch Technologies LLC

High-throughput Injectability Screening of High Concentration Protein Formulations by Microfluidic Quartz Resonators - the Objective of This Sbir Direct Phase Ii Proposal Is to Carry Qatch’s Nanovisq™ Technology, Which Is a Wide-shear-rate Range and Low Volume Viscometer for Determining Developability and Injectability of Biopharmaceutical Formulations, From Single-test Sensors to High-throughput and Automated Format. This Objective Is Motivated by the Needs of the Growing Protein-based Biopharmaceutical Therapeutics Industry (with Global Market Size Over $300 Billion). Protein-based Therapeutics Are Administered as High Concentration Formulations Due to the Volume Constraints of Subcutaneous Injections. However, Increased Protein-protein Interactions at These High Concentrations Can Cause High Viscosity and Prevent Injectability and Manufacturability. Existing Viscometers Consume High Volumes of Sample, Which Prevents Early-stage Assessment and Still Have High Protein and Time Costs at Later Stages. by Developing a High-throughput, Automated, Wide Shear Rate Range, Low Volume Viscometer, Protein Molecules and Formulations Can Be Optimized for Injectability/manufacturability Earlier With Less Cost and Risk. This Proposal Is Significant Because the Proposed Device Can Start Assessing Injectability of Protein Formulations Earlier in Drug Development, Perform This Test in a Higher Number of Formulations Faster and With Less Material Than Existing Technologies and Consequently Reduce the Time and Cost of R&D Spent in Developing New, Injectable Protein-based Therapeutics Considerably. as Preliminary Studies, Qatch Demonstrated Wide-shear-rate and Low Sample Volume Viscometers for Protein Formulations in Single- Test Format. in Addition, Qatch Showed That 4 Simultaneous Measurements From 4 Sensors With 9 MM Spacing on the Same Quartz Blank Can Be Achieved Accurately. as a Result, the Nanovisq™ Is Now Positioned to Be a 6X4 Sensor Matrix and Automated Viscometer for High Concentration Protein Formulations. in Sbir Phase Ii Qatch Is Proposing to 1) Develop 4-SENSOR Arrays With Extended Shear-rate Viscosity Measurements to Serve High- Concentration Protein Formulations 2) Develop 6X4 Sensor Matrix for the High-throughput System With Environmental Control and the Automated Sample Delivery Capability. Developing a High-throughput and Automated Low-sample Volume Viscometer Is a Key Step Towards Commercialization Since Low-sample Volume and High-throughput Are Two Most Important Parameters for Drug Development Groups.