Development and characterization of a pre-treatment procedure to eliminate human monoclonal antibody therapeutic drug and matrix interference in cell-based functional neutralizing antibody assays
Tài liệu tham khảo
Angal, 1993, A single amino acid substitution abolishes the heterogeneity of chimeric mouse/human (IgG4) antibody, Mol. Immunol., 30, 105, 10.1016/0161-5890(93)90432-B
Beck, 2008, Trends in glycosylation, glycoanalysis and glycoengineering of therapeutic antibodies and Fc-fusion proteins, Curr. Pharm. Biotechnol., 9, 482, 10.2174/138920108786786411
Beck, 2010, Strategies and challenges for the next generation of therapeutic antibodies, Nat. Rev. Immunol., 10, 345, 10.1038/nri2747
Casadevall, 2002, Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin, N. Engl. J. Med., 346, 469, 10.1056/NEJMoa011931
Civoli, 2012, Development and optimization of neutralizing antibody assays to monitor clinical immunogenicity, Bioanalysis, 4, 2725, 10.4155/bio.12.239
DeSilva, 2014, Matrix interference in ligand-binding assays: challenge or solution?, Bioanalysis, 6, 1029, 10.4155/bio.14.92
Dodge, 2009, Challenges in developing antidrug antibody screening assays, Bioanalysis, 1, 699, 10.4155/bio.09.55
Food and Drug Administration, 2013
Food and Drug Administration
Furlong, 2014, An exploratory universal LC–MS/MS assay for bioanalysis of hinge region-stabilized human IgG4 mAbs in clinical studies, Bioanalysis, 6, 1747, 10.4155/bio.14.64
Hu, 2009, A bioactive drug quantitation based approach for the detection of anti-drug neutralizing antibodies in human serum, J. Immunol. Methods, 345, 70, 10.1016/j.jim.2009.04.005
Jiang, 2014, Innovative use of LC–MS/MS for simultaneous quantitation of neutralizing antibody, residual drug, and human immunoglobulin G in immunogenicity assay development, Anal. Chem., 86, 2673, 10.1021/ac5001465
Klee, 2000, Human anti-mouse antibodies, Arch. Pathol. Lab. Med., 124, 921, 10.5858/2000-124-0921-HAMA
Lofgren, 2006, Detection of neutralizing anti-therapeutic protein antibodies in serum or plasma samples containing high levels of the therapeutic protein, J. Immunol. Methods, 308, 101, 10.1016/j.jim.2005.10.007
McCutcheon, 2010, Development and optimization of a cell-based neutralizing antibody assay using a sample pre-treatment step to eliminate serum interference, J. Immunol. Methods, 358, 35, 10.1016/j.jim.2010.03.016