Inhalable dry powders of a monoclonal antibody against SARS-CoV-2 virus made by thin-film freeze-drying.

Monoclonal antibodies (mAbs) represent a promising modality for the prevention and treatment of viral infections. For infections that initiate from the respiratory tract, direct administration of specific neutralizing mAbs into lungs has advantages over systemic injection of the same mAbs. Herein, using AUG-3387, a human-derived mAb with high affinity to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and its various variants, as a model mAb, we formulated the mAb into dry powders by thin-film freeze-drying, confirmed that the AUG-3387 mAb reconstituted from the dry powders retained their integrity, high affinity to the SARS-CoV-2 spike protein receptor binding domain (RBD), as well as ability to neutralize RBD-expressing pseudoviruses. Finally, we showed that one of the AUG-3387 mAb dry powders had desirable aerosol properties for pulmonary delivery into the lung. We concluded that thin-film freeze-drying represents a viable method to prepare inhalable powders of virus-neutralizing mAbs for pulmonary delivery into the lung.
Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Cui reports a relationship with TFF Pharmaceuticals, Inc. that includes: equity or stocks and funding grants. Williams reports a relationship with TFF Pharmaceuticals, Inc. that includes: consulting or advisory, equity or stocks, and funding grants. Xu and Moon report a relationship with TFF Pharmaceuticals, Inc. that includes: consulting or advisory. Cui, Williams, Christensen, Emig, Mena, Vitug and Henry are inventors on IP related to this work. Christensen was a consultant for TFF Pharmaceuticals. Emig, Mena, Vitug, Henry, and Ventura are or were employees of Augmenta Bioworks, Inc. ZC serves as the Editor of the International Journal of Pharmaceutics for North America. This paper was subject to all the Journal’s usual procedures. The peer review was handled, and the editorial decision was made independently of ZC and his research group.
(Copyright © 2024 Elsevier B.V. All rights reserved.)