A Multiplex Light-Scattering Method to Assess Colloidal Stability Incorporating the Diffusion Interaction Parameter Thermal Shift

CASSS AT Europe 2020 -- In monoclonal antibody (mAb) formulation development, colloidal stability and the propensity for these molecules to aggregate is a critical quality attribute, with implications for efficacy and patient safety. Using Dynamic Light Scattering, evaluation of the Diffusion Interaction Parameter (kD) is used to assess colloidal stability, measured at a single temperature. An additional parameter is the Aggregation Onset Temperature (Tonset), which is valid for a single concentration. We have developed a multiplexed assay that incorporates these two methods into a single light scattering experiment to determine a new third parameter: the Diffusion Interaction Parameter Thermal Shift Temperature (TkD).