Rapid Room-Temperature Aerosol Dehydration Versus Spray Drying: A Novel Paradigm in Biopharmaceutical Drying Technologies

• Published in: Journal of pharmaceutical sciences Vol. 113; no. 4; pp. 974 - 981
• Main Authors: Poozesh, Sadegh, Mezhericher, Maksim, Pan, Zehao, Chaudhary, Uzair, Manikwar, Prakash, Stone, Howard A.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.04.2024
• Subjects: Administration, Inhalation; Aerosol-assisted drying; Aerosols - chemistry; Biological Products; Biopharmaceutical processing; Dehydration; Freeze Drying - methods; Humans; Particle engineering; Particle Size; Powders - chemistry; Prospective Studies; Protein degradation; Spray Drying; Technology; Temperature; Spray drying; Protein degradation; Aerosol-assisted drying; Biopharmaceutical processing; Particle engineering
• ISSN: 0022-3549; 1520-6017; 1520-6017
• DOI: 10.1016/j.xphs.2023.10.003

To ensure the high quality of biopharmaceutical products, it is imperative to implement specialized unit operations that effectively safeguard the structural integrity of large molecules. While lyophilization has long been a reliable process, spray drying has recently garnered attention for its particle engineering capabilities for the pulmonary route of administration. However, maintaining the integrity of biologics during spray drying remains a challenge. To address this issue, we explored a novel dehydration system based on aerosol-assisted room-temperature drying of biological formulations recently developed at Princeton University, called Rapid Room-Temperature Aerosol Dehydration. We compared the quality attributes of the bulk powder of biopharmaceutical products manufactured using this drying technology with that of traditional spray drying. For all the fragment antigen-binding formulations tested, in terms of protein degradation and aerosol performance, we were able to achieve a better product quality using this drying technology compared to the spray drying technique. We also highlight areas for improvement in future prototypes and prospective commercial versions of the system. Overall, the offered dehydration system holds potential for improving the quality and diversity of biopharmaceutical products and may pave the way for more efficient and effective production methods in the biopharma industry.