A Novel Method for Preparing Uniform Micro-Sized Dry Powder Formulations, Including Aggregation-Controlled VHH.

Area of Science:

• Biotechnology
• Pharmaceutical Sciences
• Materials Science

Background:

• Antibody powderization is key for novel drug delivery and non-refrigerated storage.
• Variable domain of heavy-chain antibodies (VHHs) offer superior thermal stability and refolding capabilities compared to conventional antibodies.

Purpose of the Study:

• To evaluate the feasibility of using fine droplet drying (FDD) for VHH powder preparation.
• To assess the physicochemical properties, including aggregation, binding activity, particle characteristics, and inhalation properties of VHH powders (VHHps).

Main Methods:

• The fine droplet drying (FDD) process was employed for VHH powderization due to its mild conditions and uniform particle generation.
• Evaluated VHHps for aggregation, binding activity, particle size, and in vitro inhalation properties.

Main Results:

• VHH aggregation increased with higher FDD flow temperatures; however, binding activity remained comparable to native VHHs.
• Approximately 30% of VHHs lost function post-FDD, but non-degraded VHHs showed sustained functionality for over two years at room temperature.
• Generated VHHps were uniformly spherical, micron-sized particles with favorable inhalation properties.

Conclusions:

• FDD is a viable technique for producing diverse VHH powder formulations.
• The study demonstrates the potential of FDD-derived VHH powders for pharmaceutical applications, including drug delivery systems.