Drug interference in immunogenicity assays depends on valency
| Autor: | Theo Rispens, Anke Vennegoor, Joep Killestein, Desiree van der Kleij, G.J. Wolbink, M. Hart, Astrid van Leeuwen, Pleuni Ooijevaar-de Heer |
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| Přispěvatelé: | Neurology, NCA - Neuroinflamation, Landsteiner Laboratory |
| Rok vydání: | 2013 |
| Předmět: |
Drug
media_common.quotation_subject Clinical Biochemistry Pharmaceutical Science Pharmacology Antibodies Monoclonal Humanized Certolizumab Antibodies Immunoglobulin G Polyethylene Glycols Analytical Chemistry Immunoglobulin Fab Fragments Natalizumab In vivo Drug Discovery medicine Humans Certolizumab pegol Spectroscopy media_common biology Chemistry Immunogenicity Adalimumab Antibody Formation Certolizumab Pegol Immunologic Techniques biology.protein medicine.drug |
| Zdroj: | Rispens, T, Hart, M H, Ooijevaar-de Heer, P, van Leeuwen, A, Vennegoor, A, Killestein, J, Wolbink, G J & van der Kleij, D 2013, ' Drug interference in immunogenicity assays depends on valency ', Journal of Pharmaceutical and Biomedical Analysis, vol. 85, pp. 179-185 . https://doi.org/10.1016/j.jpba.2013.07.022 Journal of Pharmaceutical and Biomedical Analysis, 85, 179-185. Elsevier Journal of pharmaceutical and biomedical analysis, 85, 179-185. Elsevier |
| ISSN: | 0731-7085 |
| DOI: | 10.1016/j.jpba.2013.07.022 |
| Popis: | Direct comparison of immunogenicity data is hampered by differential drug interference in different assay formats. In this paper we identify a drug-related factor that influences the extent of drug interference. We systematically investigated the influence of drug valency of different antibody-derived biologicals on the drug interference, using mono- and bivalent formats of adalimumab as a model system. Our results indicate that compared to regular bivalent antibodies, antibody-derived drugs that are monovalent result in less drug interference. Two real-life examples were examined: natalizumab, an IgG4 antibody that becomes effectively monovalent in vivo due to Fab arm exchange, and certolizumab pegol, a pegylated Fab fragment. For both drugs it was demonstrated that drug interference is less pronounced in an antigen-binding test compared to similar assays for other therapeutic antibodies. When comparing immunogenicity data obtained for different biologicals this phenomenon should be taken into account. |
| Databáze: | OpenAIRE |
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