使用不对称流场-流分馏分析生物流体中的蛋白质、生物制剂和纳米颗粒

M. Leeman, Alejandra Castro Nilsson, L. Nilsson
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引用次数: 0

摘要

随着人们对诸如蛋白质、抗体和核酸等生物制药的兴趣日益增加,对这些成分进行表征的需求也相应增加。在早期药物开发阶段以及配方开发和质量控制阶段,在表征上花费了大量精力。通常研究的一个参数是大分子组分的大小分布,以推断是否发生聚集或降解,是否发生构象变化,或者是否与赋形剂相互作用。虽然缓冲系统或药物配方中蛋白质药物的特性很重要,但更有趣的可能是药物进入人体后的特性。生物流体中大分子的大小表征传统上是一个受到基质复杂性阻碍的领域。大量的本地成分会干扰通常应用的尺寸表征分析技术。然而,分离技术不对称流场-流分离(AF4)最近在血浆和血清成分的表征中显示出越来越多的适用性。本文综述了AF4在血浆、血清、牛奶和脑脊液中蛋白质、生物制剂和纳米颗粒分析和表征领域的一些应用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Analysis of Proteins, Biologics, and Nanoparticles in Biological Fluids Using Asymmetrical Flow Field-Flow Fractionation
With the increasing interest in biopharmaceuticals such as proteins, antibodies, and nucleic acids, there is a corresponding increase in the need for characterizing such components. Much effort is spent on characterization in the early drug development phases as well as during formulation development and quality control. One parameter that is commonly investigated is the size distribution of the macromolecular components to deduce if there is aggregation or degradation occurring, if conformational changes occur, or if there are interactions with excipients. While the properties of the protein drug in the buffer system or in the pharmaceutical formulation are important, possibly even more interesting are the properties of the drug once it enters the body. Size characterization of macromolecules in biological fluids has traditionally been an area hampered by the complexity of the matrix. The large amount of indigenous components can interfere with commonly applied analytical techniques for size characterization. However, the separation technique asymmetrical flow field-flow fractionation (AF4) has recently shown increasing applicability for the characterization of components in blood plasma and serum. This article reviews some aspects of applying AF4 to plasma, serum, milk, and cerebrospinal fluid in the field of analysis and characterization of proteins, biologics, and nanoparticles in biological fluids.
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