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.
Public Health Relevance Statement: Subcutaneous injections of protein-based therapeutics enable home administration and reduce the load on the healthcare facilities and healthcare costs. However, the injectability of protein-based formulations at the necessary high concentrations for injection cannot be determined at early stages of drug development due to a lack of material and still has high time and material costs at later stages. Our technology addresses this by allowing the measurement of viscosity at shear-rate ranges relevant to injectability and manufacturability using very small volumes of formulations. This technology will enable prescreening and optimizing proteins for injectability during early stages of drug development and reduce the risk of scaling, and the associated costs, of uninjectable proteins. In the long-term, the availability of this technology is expected to increase the number of injectable protein-based therapeutics to address patients needs.
Project Terms: Acoustic; Acoustics; Behavior; Biological Assay; Assay; Bioassay; Biologic Assays; Biological Products; Biologic Products; Biological Agent; biologics; biopharmaceutical; biotherapeutic agent; Blood capillaries; capillary; Electronics; electronic; electronic device; Health care facility; Health Facilities; Healthcare Facility; care facilities; Industry; Intravenous infusion procedures; IV Infusion; intravenous infusion; Subcutaneous Injections; subdermal injection; Investments; Marketing; Persons; Patients; Proteins; Quartz; research and development; Development and Research; R & D; R&D; Rheology; Risk; Computer software; Software; Solubility; Technology; Temperature; Testing; Time; Viscosity; Measures; Health Costs; Healthcare Costs; Health Care Costs; Injectable; customs; Custom; sensor; Chronic; Phase; Failure; Measurement; antibody based therapies; antibody treatment; antibody-based therapeutics; antibody-based treatment; Antibody Therapy; Therapeutic; instrument; Nature; Patient Preferences; Disease Management; Disorder Management; milliliter; System; Drug Formulations; Infusion procedures; Infusion; infusions; injection/infusion; Devices; Positioning Attribute; Position; Sampling; protein protein interaction; drug development; Drops; reduce risk; reduce risks; reduce that risk; reduce the risk; reduce these risks; reduces risk; reduces the risk; reducing risk; reducing the risk; risk-reducing; Risk Reduction; µfluidic; Microfluidics; preventing; prevent; small molecule; Address; Data; Resolution; resolutions; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Viral Vector; Development; developmental; cost; manufacturing process; scale up; Consumption; prototype; commercialization; FDA approved; screenings; screening; temporal resolution; time measurement; temporal measurement; Formulation; pre-clinical development; preclinical development; Injections; manufacturability; homes; Home; manufacture
