Advancing Biologics Through Nebulized Combination Delivery

Drug delivery of complex molecules and biologics via the gastrointestinal (GI) tract is limited by poor bioavailability, and injections typically require needles which can reduce adherence and user preference.

Pulmonary inhalation, and specifically nebulization, offers a compelling alternative, providing rapid systemic uptake, direct access to the lungs, and the potential for significantly improved bioavailability through a highly vascularized absorption surface. However, the successful inhalation of biologics remains a significant challenge.

Conventional inhalation and nebulization technologies can expose sensitive molecules to shear stress, air-liquid interfaces, and other forces that may compromise their structural integrity, stability, and therapeutic activity. As a result, translating biologics from injection-based therapies to inhaled formulations has proven more complex than initially anticipated.

This presentation will examine the underlying scientific and engineering barriers associated with inhaled biologics, including formulation-device interplay, aerosol physics, particle size control and lung deposition dynamics.

We will explore a new approach to aerosol generation designed to preserve biologic integrity while achieving precise and reproducible delivery, using Nebu~Flow as a case study.

The session will conclude with an illustration of how partnership between an innovative startup and a global CDMO can accelerate time to market and regulatory readiness provide scalability and global supply.