Advances in the assessment and control of the effector functions of therapeutic antibodies.

Abstract

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.

DOI: 10.1038/nrd3365

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@article{Jiang2011AdvancesIT, title={Advances in the assessment and control of the effector functions of therapeutic antibodies.}, author={Xu-Rong Jiang and An Song and Svetlana Bergelson and Thomas Arroll and Bhavin P. Parekh and Kimberly D May and Shan Chung and Robert Strouse and Anthony R. Mire-Sluis and Mark A. Schenerman}, journal={Nature reviews. Drug discovery}, year={2011}, volume={10 2}, pages={101-11} }