title: [Testing immunogenicity of recombinant antibody by surface plasmon resonance].
abstract: With the development of bio-technological drugs, drug immunogenicity evaluation has become key factor of clarifying safety and efficacy of these drugs. It has become the focus to establish a stable and reliable evaluation system. Due to the advantages such as continuous real-time monitoring, surface plasmon resonance (SPR) technology has been widely used in bio-technological drugs immunogenicity assessments. Our study applied this technology to detect anti-drug antibody (ADA) of a recombinant human anti-rabies monoclonal antibody NM57 in the sera of 48 volunteers admitted in phase I clinical trials. This method could satisfy the basic requirements of detection of ADA.
authors.affiliation: New Drug Research and Development Company Limited, North China Pharmaceutical Corporation, Shijiazhuang 050015, China.
authors.forename: Liang
authors.initials: L
authors.lastname: Chang
authors.forename: Xiao-Zhi
authors.initials: XZ
authors.lastname: Liu
authors.forename: Wei
authors.initials: W
authors.lastname: Zhao
authors.forename: Yan-Ling
authors.initials: YL
authors.lastname: Liu
authors.forename: Xiang-Feng
authors.initials: XF
authors.lastname: Dong
authors.forename: Xue-Jing
authors.initials: XJ
authors.lastname: Chen
authors.forename: Li-Min
authors.initials: LM
authors.lastname: Li
authors.forename: Yan
authors.initials: Y
authors.lastname: Jiang
authors.forename: Jian
authors.initials: J
authors.lastname: Gao
authors.forename: Jing-Shuang
authors.initials: JS
authors.lastname: Wei
mesh_terms: D000888:Antibodies, Anti-Idiotypic / Q000032:analysis* / Q000097:blood / Q000276:immunology; D000911:Antibodies, Monoclonal / Q000032:analysis* / Q000097:blood / Q000276:immunology; D000914:Antibodies, Viral / Q000032:analysis* / Q000097:blood / Q000276:immunology; D006801:Humans; D011820:Rabies virus / Q000276:immunology*; D011994:Recombinant Proteins / Q000032:analysis / Q000097:blood / Q000276:immunology; D020349:Surface Plasmon Resonance
chemical_list: D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal; D000914:Antibodies, Viral; D011994:Recombinant Proteins