Hold Tank Mixing Profile Optimization for Potency Control in Filling a Shear Thinning Suspension Formulation

This study discusses the complex mixing considerations arising throughout the time course of filling a shear-thinning suspension drug product formulation. As feed tank working volume is drawn down, rotational speed of the off-set, bottom mounted mixer must balance air entrainment, regions of stagnation, and apparent active particle buoyancy and creaming in the transitional regime without impacting potency control of the suspension drug product being filled. M-Star Simulation’s® Digital Mixing Tank (DMT) is employed to characterize the complex phenomena to inform mixing profile optimization.