盐(化学)
活性成分
化学
小瓶
生化工程
色谱法
计算机科学
药理学
医学
有机化学
工程类
作者
Juan Davagnino,John P. Gabrielson
标识
DOI:10.1016/j.xphs.2022.06.020
摘要
Obtaining an elegant finished pharmaceutical product remains a problem when salt concentration is high, protein concentration is low, and particularly when both conditions are combined. We propose a simple approach to develop a robust lyophilized formulation in the presence of salt and at low protein concentration. We combine this with a commercially viable lyophilization cycle that can serve as a starting point for many protein-based pharmaceutical products. In this manner the formulator scientist, even with little experience, can develop a robust and visually acceptable lyophilized product. In addition, this platform allows the production of placebo vials with no visual differences compared to the active product.
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