White Paper: Characterization Of Spray Dried Biologics

By Dr. Richard Johnson, Chief Scientific Officer & Founder, Upperton Pharma Solutions

This white paper delves into the expanding role of spray drying as a versatile technique for producing dry powder formulations, not only for traditional small-molecule APIs, but also for much larger and more complex biologics such as peptides, antibodies, and vaccines. While spray drying has long been used in oral drug delivery, recent advancements have broadened its application to include biologic therapeutics, offering benefits like enhanced stability, improved delivery profiles, and better patient compliance. However, formulating biologics via spray drying presents unique technical and analytical challenges. Unlike small molecules, biologics require more sophisticated assay techniques to accurately assess structural integrity, stability, and functional activity.

This paper provides a comprehensive overview of how spray drying has evolved to meet these challenges, with detailed insights into the selection of analytical methods needed to evaluate key physical, chemical, and functional attributes of spray-dried biologics. It also outlines critical strategies for preserving biologic functionality both immediately after processing and throughout storage, as well as practical considerations for developing robust and stable formulations. Together, these insights aim to support drug developers in harnessing the full potential of spray drying for next-generation biologic therapies.