Multiplexed immunoassay approach to characterize antidrug antibody like specific reactivity

Leung Sheldon; Fiorotti Corinna; Bibik Michael; Brown David; Gleeson Martin A.; Gorovits Boris

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Multiplexed immunoassay approach to characterize antidrug antibody like specific reactivity

机译：复用的免疫测定方法表征抗皱抗体等特定反应性

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Aim: Characterization of antidrug antibody (ADA)-like reactivity has emerged as critical element of bio-analytical design and assessment of compound immunogenicity risk. Materials & methods: Multiplex immunoassay was applied to detect and characterize ADA like reactivity using Photonic Ring Immunoassay platform (Genalyte). Specific binding to human IgE or human recombinant IL21-receptor-Fc fusion using exogenous reagents as surrogates for drug-specific reactivity was investigated. Results: Multiplexed assay format allowed identification of spiked antihuman IgE reactivity as murine IgG1 and endogenous antihuman recombinant IL21-receptor-Fc reactivity in rheumatoid arthritis sera as antihuman Fc-specific binding. Conclusion: The ability of a multiplex immunoassay platform to identify isotype and domain specificity of antidrug immunoglobulins was shown to be effective and should be considered when screening and characterizing pre- and post-dose ADA reactivity.

机译：目的：抗皱抗体（ADA）的表征是生物分析设计的关键因素和复合免疫原性风险的评估。材料和方法：使用光子环免疫测定平台（Genalyte）施用多重免疫测定以检测和表征ada等反应性。研究了使用外源试剂作为用于药物特异性反应性的外源试剂的人IgE或人重组IL21-受体-FC融合的特异性结合。结果：多路复用测定格式允许鉴定尖刺抗人IgE反应性，作为鼠IgG1和内源性抗人民重组IL21-受体-FC反应性为类风湿性关节炎血清，作为抗人均FC特异性结合。结论：多重免疫测定平台鉴定抗真菌免疫球蛋白的同种型和结构域特异性的能力是有效的，应当在筛选和表征前后ADA反应性时考虑。

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来源
《Bioanalysis》 |2019年第8期|共10页
作者
Leung Sheldon; Fiorotti Corinna; Bibik Michael; Brown David; Gleeson Martin A.; Gorovits Boris;
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作者单位

Pfizer 1 Burtt Rd Andover MA 01810 USA;

Pfizer 1 Burtt Rd Andover MA 01810 USA;

Genalyte 10520 Wateridge Cir San Diego CA 92121 USA;

Genalyte 10520 Wateridge Cir San Diego CA 92121 USA;

Genalyte 10520 Wateridge Cir San Diego CA 92121 USA;

Pfizer 1 Burtt Rd Andover MA 01810 USA;

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原文格式 PDF
正文语种 eng
中图分类生物科学;
关键词
ADA; antidrug antibody; domain specificity; isotyping; multiplexing;

机译：ADA;抗Rrug抗体;域特异性;同学位;多路复用;

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专利

1. Multiplexed immunoassay approach to characterize antidrug antibody like specific reactivity [J] . Leung Sheldon, Fiorotti Corinna, Bibik Michael, Bioanalysis . 2019,第8期

机译：复用的免疫测定方法表征抗皱抗体等特定反应性
2. Simultaneous Detection of Haemophilus influenzae Type b Polysaccharide-Specific Antibodies and Neisseria meningitidis Serogroup A, C, Y, and W-135 Polysaccharide-Specific Antibodies in a Fluorescent-Bead-Based Multiplex Immunoassay [J] . Richarda M. de Voer, Rutger M. Schepp, Florens G. A. Versteegh, Clinical and vaccine immunology: CVI . 2009,第3期

机译：在基于荧光珠的多重免疫测定中同时检测b型流感嗜血杆菌多糖特异性抗体和脑膜炎奈瑟氏球菌血清A，C，Y和W-135多糖特异性抗体
3. Pandemic influenza A(H1N1 pdm09) vaccine induced high levels of influenza-specific IgG and IgM antibodies as analyzed by enzyme immunoassay and dual-mode multiplex microarray immunoassay methods [J] . Kazakova Anna, Kakkola Laura, Ziegler Thedi, Vaccine . 2020,第8期

机译：大流行性流感A（H1N1 PDM09）疫苗诱导高含量的甲型甲型特异性IgG和IgM抗体，如酶免疫测定和双模多重微阵列免疫测定方法分析
4. Multiplex detection of IgG class antibodies to Toxoplasma gondii, Rubella virus, Cytomegalovirus and Herpes virus using a novel multiplex flow immunoassay [C] . Dolgushin Sergey, Selishchev Sergey, Loseva Ekaterina, 2015 International Conference on Biomedical Engineering and Computational Technologies . 2015

机译：使用新型多重流免疫测定法对弓形虫，风疹病毒，巨细胞病毒和疱疹病毒的IgG类抗体进行多重检测
5. Specificity of somatostatin receptor and G-protein interactions as characterized by somatostatin receptor subtype specific antibodies. [D] . Gu, Yi-Zhong. 1996

机译：以生长抑素受体亚型特异性抗体为特征的生长抑素受体和G蛋白相互作用的特异性。
6. Evaluation of the Cross-reactivity of Antidrug Antibodies to CT-P13 and Infliximab Reference Product (Remicade): An Analysis Using Immunoassays Tagged with Both Agents [O] . Walter Reinisch, Jørgen Jahnsen, Stefan Schreiber, -1

机译：评价抗药抗体对CT-P13和英夫利昔单抗参比药物（Remicade）的交叉反应性：使用两种试剂标记的免疫分析方法进行的分析
7. Simultaneous Detection of Haemophilus influenzae Type b Polysaccharide-Specific Antibodies and Neisseria meningitidis Serogroup A, C, Y, and W-135 Polysaccharide-Specific Antibodies in a Fluorescent-Bead-Based Multiplex Immunoassay ▿ [O] . de Voer, Richarda M., Schepp, Rutger M., Versteegh, Florens G. A., 2009

机译：在基于荧光珠的多重免疫分析中同时检测b型流感嗜血杆菌多糖特异性抗体和脑膜炎奈瑟氏球菌血清A，C，Y和W-135多糖特异性抗体saccharide

Multiplexed immunoassay approach to characterize antidrug antibody like specific reactivity

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