Inhalable and Nasal Biologics: Analytical, Formulation, Development, and Regulatory Considerations

Background: Delivering large molecules and biologics via inhalation or intranasal routes allows these innovative therapies to directly target the respiratory tract, access the richly vascularized lymphatic tissue in the nose for vaccination, bypass gastro-intestinal and first-pass hepatic metabolism for systemically active drugs, and provide a convenient alternative to injections. These advantages are driving significant growth in research and development within this field. However, before such products can reach the market, they must undergo rigorous nonclinical studies and clinical trials and address challenges related to formulation, manufacturing, analytical testing, quality standards, and regulatory review.