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应用于蛋白质类生物制药制剂特征分析和开发研究中的紫外光、可见光和红外光成象技术。

Application of ultraviolet, visible, and infrared light imaging in protein-based biopharmaceutical formulation characterization and development studies.

机构信息

Department of Biotechnology, Delft University of Technology, Van der Maasweg 9, Delft 2629 HZ, the Netherlands.

Institute of Engineering in Life Sciences, Section IV: Biomolecular Separation Engineering, Karlsruhe Institute of Technology (KIT), Fritz-Haber-Weg 2, 76131 Karlsruhe, Germany.

出版信息

Eur J Pharm Biopharm. 2021 Aug;165:319-336. doi: 10.1016/j.ejpb.2021.05.013. Epub 2021 May 27.

Abstract

Imaging is increasingly more utilized as analytical technology in biopharmaceutical formulation research, with applications ranging from subvisible particle characterization to thermal stability screening and residual moisture analysis. This review offers a comprehensive overview of analytical imaging for scientists active in biopharmaceutical formulation research and development, where it presents the unique information provided by the ultraviolet (UV), visible (Vis), and infrared (IR) sections in the electromagnetic spectrum. The main body of this review consists of an outline of UV, Vis, and IR imaging techniques for several (bio)physical properties that are commonly determined during protein-based biopharmaceutical formulation characterization and development studies. The review concludes with a future perspective of applied imaging within the field of biopharmaceutical formulation research.

摘要

成像技术在生物制药制剂研究中越来越多地被用作分析技术,其应用范围从亚可见颗粒特征分析到热稳定性筛选和残余水分分析。本综述为活跃在生物制药制剂研究和开发领域的科学家提供了分析成像的全面概述,介绍了电磁光谱中紫外线 (UV)、可见光 (Vis) 和红外线 (IR) 部分提供的独特信息。本综述的主要内容包括用于几种(生物)物理特性的 UV、Vis 和 IR 成像技术概述,这些特性通常在基于蛋白质的生物制药制剂特性描述和开发研究中确定。综述最后对生物制药制剂研究领域应用成像的未来前景进行了展望。

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