Antibodies against erythropoietin and other protein-based therapeutics - An overview

被引：41

作者：

Kromminga, A

Schellekens, H

机构：

[1] IPM, Mol Med, Clin Pathol, Inst Immunol, D-22339 Hamburg, Germany

[2] Univ Utrecht, Cent Lab, Anim Inst, Utrecht, Netherlands

[3] Univ Utrecht, Dept Innovat Studies, Utrecht, Netherlands

来源：

AUTOIMMUNITY: CONCEPTS AND DIAGNOSIS AT THE CUTTING EDGE | 2005年 / 1050卷

关键词：

antibodies; assay; erythropoietin (EPO); immunogenicity; protein; therapeutics;

D O I：

10.1196/annals.1313.027

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

Many factors influence the immunogenicity of protein-based therapeutics. At present, it is inconceivable to manufacture a biopharmaceutical without the risk of this adverse effect. Thus, the detection and characterization of antibodies against protein-based therapeutics is a significant task. Only clinical studies and careful monitoring of the market can be used to conclusively demonstrate rates of immunogenicity in humans for protein therapeutics. Fully validated, reliable, and robust in vitro assays, in combination with sensitive bio-assays, should be used to address these topics.

引用

页码：257 / 265

页数：9

共 28 条

[1] Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. [J].