Steć Aleksandra, Heinz Andrea, Dziomba Szymon
Department of Toxicology, Faculty of Pharmacy, Medical University of Gdansk, 80-416 Gdansk, Poland.
LEO Foundation Center for Cutaneous Drug Delivery, Department of Pharmacy, University of Copenhagen, 2100 Copenhagen, Denmark.
J Pharm Anal. 2024 Dec;14(12):101004. doi: 10.1016/j.jpha.2024.101004. Epub 2024 May 23.
Extracellular vesicles (EVs) are a part of a cell-to-cell communication system of prokaryotic and eukaryotic organisms. Their ability to penetrate biological barriers and to transfer molecules between cells shows their potential as a novel class of drug delivery platform. However, because of the great heterogeneity of EVs and the complexity of biological matrices from which they are typically isolated, reliable quality control procedures need to be established to ensure their safety for medical use. According to current recommendations, quantification of EVs, confirmation of their identity, and purity assessment require the use of several analytical techniques, including particle-size distribution analysis, proteomics, and electron microscopy, making the characterization process demanding. Capillary electrophoresis (CE) has recently emerged as an alternative tool for EV characterization. In this study, the available literature on this novel concept for EV characterization was reviewed. Its performance was critically evaluated and compared with currently used methods. The utility of CE in the quality control of EV-based medicines was discussed.
细胞外囊泡(EVs)是原核生物和真核生物细胞间通讯系统的一部分。它们穿透生物屏障以及在细胞间传递分子的能力显示出其作为一类新型药物递送平台的潜力。然而,由于EVs具有高度异质性,且其通常从中分离的生物基质复杂,因此需要建立可靠的质量控制程序以确保其医疗使用的安全性。根据当前建议,EVs的定量、身份确认和纯度评估需要使用多种分析技术,包括粒度分布分析、蛋白质组学和电子显微镜,这使得表征过程颇具挑战性。毛细管电泳(CE)最近已成为EVs表征的替代工具。在本研究中,对有关这一EVs表征新概念的现有文献进行了综述。对其性能进行了严格评估,并与目前使用的方法进行了比较。还讨论了CE在基于EVs的药物质量控制中的效用。