Impact of Excipients on Stability of the Spray-Dried Protein Formulations

Solid protein formulations are developed to offer better physical and chemical stability as compared to the formulations in solution-state. Lyophilization is the most commonly used drying technique to produce protein solids. However, lyophilization is a batch process that is time- and energy-intensive; other alternative drying techniques are being considered to produce solid protein formulations such as spray drying. While spray drying offers advantages in terms of material properties and processing time, process stresses such as high temperature, atomization stresses, and air-liquid interfacial stresses may have an impact on the stability of the spray-dried protein solids. Excipients are often added improve their stability. In the seminar, we will present our recent work on understanding the impact of excipients on stability of spray-dried solid formulation of proteins using advanced solid characterization techniques such as solid-state hydrogen/deuterium exchange with mass spectrometric analysis (ssHDX-MS), solid-state nuclear magnetic resonance spectroscopy (ssNMR) and X-ray photoelectron spectroscopy (XPS). Our work showed that excipients have critical impact on the solid-state properties and stability of spray dried protein formulations. Advanced analytical techniques are essential to capture and understand how excipients affect formulation stability, with a goal to ensure the quality of solid protein products. This presentation highlights the importance of excipients on development of novel dosage forms for pharmaceutical biologics products.