The preferred mode of delivering high-concentration protein drug formulations (HCFs, >100 mg/mL) is subcutaneous or intramuscular injection, which enables home administration, short treatment times, and sustainable release. However, the elevated viscosity of HCFs often affect formulation development and injectability. Timely measurement of viscosity at early stages is crucial to prevent these challenges. Yet, conventional viscometers demand high sample volumes, impeding early-stage assessments and entailing substantial material and time costs. To address these challenges, QATCH developed the nanovisQ™, an acoustofluidic device that measures viscosity for a wide range of shear-rates (100 1/s- 15,000,000 1/s) with extremely small sample volume (3-5 μl) in less than 10 minutes. Using nanovisQ™, we compared the viscosity of human IgG, bovine IgG, and bovine serum albumin in different buffers, with higher concentrations causing higher viscosity at low shear (1,000-50,000 1/s) and more pronounced shear-thinning. At ultra-high shear rates (15,000,000 1/s), all samples exhibited lower viscosity. These viscosities were then mapped to injection force using standard solutions and confirmed by direct measurement. We measured the viscosity of BGG solutions in a 4x1 multiplex array, consuming only 5 μL per sample in 200 seconds, yielding viscosity information faster and over a wider range than possible with competing technologies. Taken together, these properties make nanovisQ™ an optimal tool for characterizing the viscosity of HCFs before preclinical scale-up and better capture shear behavior over the life of the drug.
Learning Objectives:
Upon completion, participants will be able to evaluate and leverage broad-shear, low-volume viscometry using nanovisQ™ to enhance drug candidate selection and accelerate formulation development.
Upon completion, participants will be able to think critically about the physics underlying commonplace industry methods, with the goal of improving these techniques for a rapidly evolving research environment.
Upon completion, participants will be able to determine which features of a viscometry measurement are most critical for their own work.