生物制药
喷雾干燥
冷冻干燥
工艺工程
脱水
机组运行
气溶胶
环境科学
纳米技术
材料科学
化学
色谱法
化学工程
生物技术
工程类
有机化学
生物化学
生物
作者
Sadegh Poozesh,Maksim Mezhericher,Zehao Pan,Uma Chaudhary,Prakash Manikwar,Howard A. Stone
标识
DOI:10.1016/j.xphs.2023.10.003
摘要
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.
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