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

Autor:	Poozesh S; Dosage Form Design and Development, BioPharmaceuticals Development, R&D, AstraZeneca, Gaithersburg, Maryland 20878, USA. Electronic address: sadegh.poozesh@gmail.com., Mezhericher M; Department of Mechanical and Aerospace Engineering, Princeton University, Princeton, New Jersey 08544, USA., Pan Z; Department of Mechanical and Aerospace Engineering, Princeton University, Princeton, New Jersey 08544, USA., Chaudhary U; Dosage Form Design and Development, BioPharmaceuticals Development, R&D, AstraZeneca, Gaithersburg, Maryland 20878, USA., Manikwar P; Dosage Form Design and Development, BioPharmaceuticals Development, R&D, AstraZeneca, Gaithersburg, Maryland 20878, USA., Stone HA; Department of Mechanical and Aerospace Engineering, Princeton University, Princeton, New Jersey 08544, USA.
Jazyk:	angličtina
Zdroj:	Journal of pharmaceutical sciences [J Pharm Sci] 2024 Apr; Vol. 113 (4), pp. 974-981. Date of Electronic Publication: 2023 Oct 05.
DOI:	10.1016/j.xphs.2023.10.003
Abstrakt:	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. Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this article. (Copyright © 2023 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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