Formulation, Drug Product, and Delivery: Considerations for Fc‐Fusion Proteins

This chapter contains sections titled: Challenges of Molecule Design and Protein Formulation The Promise of Fc-Fusion Proteins Current Landscape of Commercial Antibody-Related Products Fc Conjugates Compared to mAb Counterparts Factors in Selecting Liquid versus Lyophilized Formulations Advantages and Disadvantages of a Lyophilized Product The General Lyophilization Formulation Strategy for Fc-Fusion Proteins Bulking Agent Surfactant The Impact of Residual Moisture Practical Considerations for Low-Protein-Concentration Lyophilized Products Drug Delivery Considerations Device Considerations Assessing Feasibility of a Multidose Formulation Overage Considerations Summary