Developing prototype injectability and developability testing system based on microfluidic quartz resonators

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The objective of this SBIR 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 proof-of-concept to deployable, and reliable prototypes. This objective is motivated by the needs of the growing protein-based biopharmaceutical therapeutics industry (with global market size over $100 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 injectability and manufacturability issues, which cannot be determined at early stages of drug development due to the high sample volume requirements of conventional rheology techniques. By developing a wide shear rate range, low volume viscometer, protein molecules can be optimized for injectability/manufacturability and candidates with better developability can be selected for scaling-up. This proposal is significant because the proposed device can assess injectability of protein formulations earlier in drug development than existing technology and consequently reduce the time and cost of R&D spent in developing new, injectable protein-based therapeutics considerably. In SBIR Phase I studies, QATCH has successfully extended the shear-rate range of viscosity measurements of the nanovisQ™ for proper characterization of the high concentration protein solutions. As a result, the nanovisQ™ is now positioned to be a good fit for viscosity measurements of high concentration protein formulations. In SBIR Phase II QATCH is proposing to 1) develop a sacrificial poly-Si based fabrication process to build microfluidics on quartz wafers, 2) develop a prototype control and data acquisition module for nanovisQ™ sensors. Developing deployable and reliable nanovisQ™ sensors and instruments will be a key step in commercialization of this technology.