The formation of subvisible particles (SVPs) in monoclonal antibody (mAb) poses significant challenges for assessing the developability and stability of the drug products. Throughout the lifecycle of biopharmaceutical development and manufacturing, mAbs are subjected to diverse interfacial stresses and encounter various container surfaces. This study leverages quartz crystal microbalance with dissipation (QCM-D), an interfacial characterization technique, as well as both in-silico and empirically measured physicochemical properties, to investigate the significant differences in SVP formation among different mAbs due to interfacial stresses. We conducted forced degradation experiments in borosilicate glass and high-density polyethylene (HDPE) containers, using agitation and stirring to rank fifteen mAbs based on SVP propensity. Our data indicate that the kinetics of antibody adsorption to solid-liquid interfaces correlate strongly with SVP propensity in the stirring study, yet show a weaker correlation with agitation-induced SVPs.
Learning Objectives:
Upon completion, participant will be able to understand the significance of using quartz crystal microbalance with dissipation (QCM-D) for interfacial characterization as well as SVP prediction.
