Continuous Electrospraying of Inhalable Biological Drug Products: Novel Formulation and Manufacturing Technology

Area of Science:

• Pharmaceutical Manufacturing
• Biotechnology
• Materials Science

Background:

• Traditional batch pharmaceutical manufacturing faces challenges including downtime, high carbon footprint, contamination risks, and increased costs.
• Oral delivery of biologics is hindered by degradation and poor gastrointestinal absorption, necessitating alternative delivery methods.

Purpose of the Study:

• To develop and evaluate a continuous manufacturing platform utilizing electrospraying.
• To produce a dry powder inhalation (DPI) formulation of biologics using this platform.

Main Methods:

• A continuous electrospraying system was designed to create biodegradable PLGA core-shell microparticles encapsulating bovine serum albumin (BSA) and insulin.
• Microparticles were adhered to lactose carriers using a conveyor-belt collection setup.
• Particle morphology, protein distribution, secondary structure, conformational stability, encapsulation efficiency, and in vitro release were analyzed.

Main Results:

• Electrospraying successfully generated 4-20 µm PLGA core-shell microparticles uniformly attached to lactose carriers.
• Protein structure was minimally altered during processing, as confirmed by FTIR and CD analysis.
• The formulation exhibited 78.16% encapsulation efficiency and 72% cumulative protein release within 12 hours.

Conclusions:

• The electrospraying-based continuous manufacturing platform shows significant potential for scalable production of stable, biologic-loaded DPI formulations.
• This approach effectively encapsulates sensitive proteins while maintaining structural integrity, indicating promise for future inhalable biologic delivery applications.