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

被引：235

作者：

Jiang, Xu-Rong ^{[1
]}

Song, An ^{[2
]}

Bergelson, Svetlana ^{[3
]}

Arroll, Thomas ^{[4
]}

Parekh, Bhavin ^{[5
]}

May, Kimberly ^{[6
]}

Chung, Shan ^{[2
]}

Strouse, Robert ^{[1
]}

Mire-Sluis, Anthony ^{[7
]}

Schenerman, Mark ^{[1
]}

机构：

[1] Medimmune Inc, Analyt Biochem, Gaithersburg, MD 20878 USA

[2] Genentech Inc, BioAnalyt Sci, San Francisco, CA 94080 USA

[3] Biogen Idec Inc, Analyt Dev, Cambridge, MA 02142 USA

[4] Amgen Inc, Cellular Resources, Seattle, WA 98119 USA

[5] Eli Lilly & Co, Bioassay Dev, Indianapolis, IN 46221 USA

[6] Merck & Co Inc, Biol Mfg Sci & Commercializat, Union, NJ 07083 USA

[7] Amgen Inc, Global Product Qual & Qual Sci, Thousand Oaks, CA 91320 USA

来源：

NATURE REVIEWS DRUG DISCOVERY | 2011年 / 10卷 / 02期

关键词：

FC-GAMMA-RIII; COMPLEMENT-DEPENDENT CYTOTOXICITY; C-RECEPTOR POLYMORPHISMS; HUMAN IGG1; MONOCLONAL-ANTIBODY; N-ACETYLGLUCOSAMINE; ANTITUMOR-ACTIVITY; GLYCOSYLATION; RITUXIMAB; CELLS;

D O I：

10.1038/nrd3365

中图分类号：

Q81 [生物工程学（生物技术）]; Q93 [微生物学];

学科分类号：

071005 ; 0836 ; 090102 ; 100705 ;

摘要：

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.

引用

页码：101 / 110

页数：10

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