Abstract: Physical instability of pharmaceutical proteins in the solution state may necessitate the need to develop products in the solid form, due to their enhanced stability and ease of transport. Spray-drying has attracted increasing interests in manufacturing biological solids because it is a continuous process with high output rate and has capability to achieve satisfactory powder flowability by manipulating the particles’ properties. Understanding the impact of formulation conditions on the distribution of protein and its structure can aid designing drying conditions to create more homogeneous drug products with robust stability. In this presentation, we will share the case study of understanding the impact of protein-excipient interactions and miscibility on physical stability of spray dried protein solids through advanced characterization.
Learning Objectives:
To overview the current efforts on engineering technologies in solid state biological formulation. Spray drying biologics will be presented.
Advanced experimental biophysical and biochemical characterization for phase separation and mobility will be presented. Opportunities and challenges on enhancing stability from scientific rationales of characterization will be discussed
Understanding of molecular mechanism in stabilization of solid-state protein formulation will be presented, assisting the rational selection of excipients in ensuring the stability of dry biologic formulation.
