Abstract: The phase behavior of the active pharmaceutical ingredient (API) and excipients in multi-component pharmaceutical systems, during the various stages of freeze-drying, is a complex interplay of formulation variables and processing conditions. Rational drug product and process development necessitate: (i) a thorough characterization of the phase transitions of API and the excipients in the frozen state and during freeze-drying, (ii) gaining an understanding of the crystallization tendency of API and excipients during processing, and (iii) identifying the physicochemical stability requirements and critical quality attributes of the product. Case studies will be presented detailing the complex interplay of the phase behavior of API and excipients and their influence on protein stability.
Learning Objectives:
To overview the current efforts on engineering technologies in solid state biological formulation. Spray drying biologics and freezing drying of LNPs 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.
