Optimizing Lyophilized Cake Appearance: Case Studies in Monoclonal Antibody Formulations

Introduction: Lyophilization allows to extend shelf-life and stability of biologic protein-based parenteral drug products. Critical quality attributes of an ideal lyophilizate include short reconstitution times and a uniform, “elegant” cake appearance (1). However, defects like cake cracking and lyo ring formation can impact product quality and market acceptance (2). Hereby we present two case studies: elimination of cake cracking in a Phase III monoclonal antibody (mAb) and an investigation on the factors leading to a lyo ring formation on a commercialized Phase IV mAb.