1. Advances in the assessment and control of the effector functions of therapeutic antibodies.
- Author
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Xu-Rong Jiang, An Song, Bergelson, Svetlana, Arroll, Thomas, Parekh, Bhavin, May, Kimberly, Shan Chung, Strouse, Robert, Mire-Sluis, Anthony, Schenerman, Mark, Jiang, Xu-Rong, Song, An, and Chung, Shan
- Subjects
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DRUG development , *DRUG efficacy , *STRUCTURE-activity relationship in pharmacology , *DRUG receptors , *CHEMICAL affinity , *THERAPEUTIC use of immunoglobulins , *THERAPEUTIC use of monoclonal antibodies , *ANIMALS , *CRYSTALLIZATION , *IMMUNOGLOBULINS , *MONOCLONAL antibodies , *RECOMBINANT proteins , *THERAPEUTICS - 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. [ABSTRACT FROM AUTHOR]
- Published
- 2011
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