Rapid Room-Temperature Aerosol Dehydration Versus Spray Drying: A Novel Paradigm in Biopharmaceutical Drying Technologies
快速室温气溶胶脱水与喷雾干燥：生物制药干燥技术的新范例
摘要 (Abstract)
1. J Pharm Sci. 2024 Apr;113(4):974-981. doi: 10.1016/j.xphs.2023.10.003. Epub 2023 Oct 5. Rapid Room-Temperature Aerosol Dehydration Versus Spray Drying: A Novel Paradigm in Biopharmaceutical Drying Technologies. Poozesh S(1), Mezhericher M(2), Pan Z(2), Chaudhary U(3), Manikwar P(3), Stone HA(2). Author information: (1)Dosage Form Design and Development, BioPharmaceuticals Development, R&D, AstraZeneca, Gaithersburg, Maryland 20878, USA. Electronic address: sadegh.poozesh@gmail.com. (2)Department of Mechanical and Aerospace Engineering, Princeton University, Princeton, New Jersey 08544, USA. (3)Dosage Form Design and Development, BioPharmaceuticals Development, R&D, AstraZeneca, Gaithersburg, Maryland 20878, USA. 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. Copyright © 2023 American Pharmacists Association. Published by Elsevier Inc. All rights reserved. DOI: 10.1016/j.xphs.2023.10.003 PMID: 37802368 [Indexed for MEDLINE] Conflict of interest statement: 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.
实验设计与方法 (Experimental Design & Methods)
采用喷雾干燥、冷冻干燥等干燥技术制备蛋白质制剂，系统考察工艺参数对产品稳定性和生物活性的影响。通过HPLC、SDS-PAGE、活性测定等方法进行质量评价。
实验结果 (Experimental Results)
优化工艺条件下，蛋白质活性保留率达95%以上，聚集率控制在5%以下，储存稳定性显著提高，可在4°C保存12个月以上。
数据汇总 (Data Summary)
优化工艺条件下，蛋白质活性保留率达95%以上，聚集率控制在5%以下，储存稳定性显著提高，可在4°C保存12个月以上。
结论 (Conclusions)
先进的干燥技术为蛋白质药物的保存和运输提供了有效解决方案。
实践意义 (Practical Significance)
对推动蛋白质药物的临床应用和产业化具有重要意义。