Advances in the assessment and control of the effector functions of therapeutic antibodies
Advances in the assessment and control of the effector functions of therapeutic antibodies
复制标题
DOI：
10.1038/nrd3365
复制
发表时间：
2011-02-01
影响因子：
120.1
通讯作者：
Schenerman, Mark
中科院分区：
文献类型：
--
作者：
Jiang, Xu-Rong;Song, An;Schenerman, Mark
治疗性抗体的Fc（可结晶片段）区可在其安全性和功效中具有重要作用。尽管对抗体的结构-活性关系和影响Fc效应子功能的因素了解很多，但尚未定义一种方法来明确描述在抗体开发和生产期间应如何评估和控制Fc功能。在这篇文章中，我们总结了目前的抗体Fc功能的知识，提供了一个策略，用于评估不同类别的治疗性抗体（包括Fc融合蛋白）的效应器功能，并提出了一个路径，为抗体产品的制造商的常规测试和控制。
The Fc (crystallizable fragment) region of therapeutic antibodies can have an important role in their safety and efficacy. Although much is known about the structure-activity relationship of antibodies and the factors that influence Fc effector functions, a process has not yet been defined to clearly delineate how Fc functionality should be assessed and controlled during antibody development and manufacturing. In this article, we summarize the current knowledge of antibody Fc functionality, provide a strategy for assessing the effector functions of different classes of therapeutic antibodies (including Fc fusion proteins) and propose a path for routine testing and controls for manufacturers of antibody products.