Inhaled peptides and proteins show great promise for respiratory and systemic disease treatment. This class of molecules is particularly well suited to formulation and processing by spray-drying to achieve respirable engineered particles. This webinar describes formulation and process development for a novel inhaled biotherapeutic, an insulin dry-powder inhalation (DPI) formulation, as well as important preclinical in vivo modeling methodologies required to understand biologic performance. The performance of the novel spray-dried powder is compared to that of Exubera™.