This IPAC-RS Workshop served as a meeting place for industry and regulatory thought leaders to consider the burgeoning field of pulmonary and nasal delivery of biologics.  In developing these types of products, the general principles of pharmaceutical aerosol generation for safe and effective delivery to the respiratory tract need to be combined with the approaches and techniques suitable for large, complex, and generally fragile entities that fall under the umbrella of biologics.
 

The Workshop speakers and attendees discussed the practical and regulatory considerations regarding analytical method
establishment, formulation design and development, device selection, manufacturing, stability, characterization, and control of inhaled and nasal large molecule formulations. Discussions included proteins and peptides, oligonucleotides, DNAs and RNAs, antibodies, phages and other novel modalities. 

Through podium presentations from expert speakers and roundtable discussions, attendees identified current gaps in regulatory science of inhaled and nasal biologics and consider ways to address those gaps through targeted initiatives to be pursued after the Workshop.

​

This hybrid event brought together industry experts to discuss the key challenges facing developers of inhaled and nasal biologics. In-person breakout sessions will focus on three major areas: (A) Formulation Approaches, Delivery Technologies and Manufacturing of Biologic Products; (B) Analytical Testing & Control Strategies; (C) Safety Considerations & Toxicological Testing.  

​