Considerations for the development of therapeutic monoclonal antibodies

被引：58

作者：

Swann, Patrick G. ^{[1
]}

Tolnay, Mate ^{[1
]}

Muthukkumar, Subramanian ^{[1
]}

Shapiro, Marjorie A. ^{[1
]}

Rellahan, Barbara L. ^{[1
]}

Clouse, Kathleen A. ^{[1
]}

机构：

[1] US FDA, Div Monoclonal Antibodies, Ctr Drug Evaluat & Res, Bethesda, MD 20892 USA

来源：

CURRENT OPINION IN IMMUNOLOGY | 2008年 / 20卷 / 04期

关键词：

D O I：

10.1016/j.coi.2008.05.013

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

An increasing number of Investigational New Drug (IND) applications for therapeutic monoclonal antibodies (mAbs) have been submitted to US FDA over the past several years. Monoclonal antibodies and related products are under development for a wide range of indications. In addition, the diversity of anti body-related products is increasing including IgG2/IgG4 subclasses and engineered Fc regions to enhance or reduce antibody effector functionality. Recent findings highlight the need to more fully characterize these products and their activity. Advances in product characterization tools, immunogenicity assessments, and other bioanalytical assays can be used to better understand product performance and facilitate development.

引用

页码：493 / 499

页数：7

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