2026 CRBE Summit East - Innovations in Controlled Release, Bioavailability Enhan

Amorphous solid dispersions (ASDs) are supersaturating formulations that enhance both the
High-dose biologic drug products have become increasingly prevalent for treating chronic diseases across diverse therapeutic areas, with subcutaneous (SC) self-administration emerging as the preferred delivery route driven by patient and healthcare provider demand. However, developing these products presents unique complexities requiring careful strategic planning and robust development strategies. This presentation provides a comprehensive analysis of SC combination drug product development, focusing on the critical interplay between high-concentration formulation design, delivery device selection, and biopharmaceutical attributes that collectively minimize clinical risk factors. Key developmental challenges addressed include formulation strategies for achieving therapeutic doses, large-volume delivery through optimized drug-device combinations, pharmacokinetic (PK) bridging risk assessment, and patient tolerability considerations. By integrating formulation science, device engineering, and clinical bridging strategies, this presentation offers guidance for successfully navigating the complex development pathway of high-dose SC biologics from concept to commercialization.