期刊
JOURNAL OF SEPARATION SCIENCE
卷 45, 期 12, 页码 2077-2092出版社
WILEY-V C H VERLAG GMBH
DOI: 10.1002/jssc.202200112
关键词
Antidrug antibodies; Binding assay; Biopharmaceuticals; Immunogenicity; Monoclonal antibodies
资金
- National Science Foundation [CMI 2108881]
- National Institutes of Health [R01 DK069629]
- University of Nebraska Research Council
Antibody-based therapeutic agents and other biopharmaceuticals are widely used in the treatment of various diseases. However, they may cause immune reactions that reduce the drug's efficacy and lead to side effects. The immunogenicity of biopharmaceuticals can be evaluated by detecting and measuring antidrug antibodies. This review discusses various methods for antidrug antibody detection and analysis, including immunoassays and antigen binding tests.
Antibody-based therapeutic agents and other biopharmaceuticals are now used in the treatment of many diseases. However, when these biopharmaceuticals are administrated to patients, an immune reaction may occur that can reduce the drug's efficacy and lead to adverse side-effects. The immunogenicity of biopharmaceuticals can be evaluated by detecting and measuring antibodies that have been produced against these drugs, or antidrug antibodies. Methods for antidrug antibody detection and analysis can be important during the selection of a therapeutic approach based on such drugs and is crucial when developing and testing new biopharmaceuticals. This review examines approaches that have been used for antidrug antibody detection, measurement, and characterization. Many of these approaches are based on immunoassays and antigen binding tests, including homogeneous mobility shift assays. Other techniques that have been used for the analysis of antidrug antibodies are capillary electrophoresis, reporter gene assays, surface plasmon resonance spectroscopy, and liquid chromatography-mass spectrometry. The general principles of each approach will be discussed, along with their recent applications with regards to antidrug antibody analysis.
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