BPS2026 - Beyond arginine: Strategy for viscosity reduction in high-concentration formulations

The development of high-concentration biologic formulations presents unique challenges, particularly in managing viscosity while preserving stability and manufacturability. This presentation introduces a toolkit-driven strategy for formulation screening that integrates biophysical characterization early in the development process. By systematically evaluating pH conditions, buffer systems, and a range of viscosity-reducing agents, the approach enables rational selection of formulation components tailored to the molecular behavior of monoclonal antibodies and mAb-like molecules. The toolkit supports informed decision-making through viscosity profiling, stability assessments, and manufacturability considerations, offering a flexible framework to streamline formulation development. This methodology empowers scientists to design patient-friendly, high-performance therapeutics with optimized physical properties.