Additive effects of the new viscosity-reducing and stabilizing excipients for monoclonal antibody formulation: test compound properties and measurements

The table is the supporting information for a journal article with the research data used. The table includes data about the structures and physico-chemical properties of the selected compounds that were tested as viscosity-reducing compounds. The potential toxicity of the test compounds evaluated by the knowledge-based expert system Nexus Derek (Lhasa Limited, Leeds, UK) and its knowledge base Derek KB 2020 1.0 is evaluated. The table also includes the viscosity, monoclonal antibody concentration, evaluation of the viscosity reduction, and stability measurement data of the starting formulation with a model monoclonal antibody containing the test compounds at different concentrations and/or combinations. The viscosity was measured at 25 °C using a viscometer-rheometer (RheoSense m-VROC, Viscometer/Rheometer-On-a-Chip) based on microfluidic and MEMS (Micro-Electro-Mechanical systems) technologies. Viscosity reduction The viscosity reduction was calculated as a relative decrease in viscosity (%) of the sample containing the test compound compared to the starting formulation without the test compound at the same mAb concentration, which was calculated using an exponential calibration curve. RStudio: Integrated Development for R. RStudio, RStudio Team (2019) was used. The stability data includes aggregate growth and monomer percentage after preparation and after storage at 4 and 40 °C for 4 and 12 weeks observed by size exclusion chromatography (SEC). Additionally, dynamic light scattering (DLS) and static light scattering (SLS) results include the diffusion interaction parameter (kD) and second virial coefficient (B22).