Navigating the Application of Beta-Cyclodextrin in Protein Drug Product

The stabilization effects of using Beta-Cyclodextrin as an excipient will be revealed and discussed, alongside challenges in formulation development. The mechanism by which Beta-Cyclodextrin protects proteins and inhibits protein aggregation will be illustrated. Moreover, the concerns and challenges of applying Beta-Cyclodextrin in formulations will be systematically reviewed, including its impact on thermal stability, Tg’, viscosity, and osmolality of the drug product. Furthermore, the compatibility issues between Beta-Cyclodextrin and other excipients in the solution will be discussed, supported by various analytical results. The challenges of developing multi-component solution systems, especially with certain excipients, will be highlighted. The physical compatibility of Beta-Cyclodextrin with other components will be illustrated through a phase diagram and multivariate analysis. Overall, this presentation aims to highlight the role of using Beta-Cyclodextrin at optimized concentrations to prevent protein aggregation in liquid formulations. It will also list the key factors to consider in formulation design, including the rational selection of its concentration. The audience will gain valuable insights into the specific roles of Beta-Cyclodextrin in impacting the critical quality attributes of protein-based drug products.