Protein drug substance and drug products typically include excipients to ensure physical and chemical stability of protein during processing and storage. Such multi-component systems can provide numerous possibilities of protein-excipient and excipient-excipient interactions, leading to loss of excipient functionality and compromised protein stability. Considerations of protein-excipient interaction can help improve developmental timeline.
Learning Objectives:
Understanding the significance of ‘function-specific’ solid-state of excipients in lyophilized protein formulations
Demonstrate the influence of process parameters and formulation components on function-specific solid-state
Discuss techniques to understand protein-excipient interaction
Demonstrate importance of physical form of mannitol in protein formulations- lyoprotectant crystallization and protein stability
Buffer component crystallization and protein aggregation
