Feedback from the European Bioanalysis Forum: focus workshop on current analysis of immunogenicity: best practices and regulatory hurdles.
| العنوان: | Feedback from the European Bioanalysis Forum: focus workshop on current analysis of immunogenicity: best practices and regulatory hurdles. |
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| المؤلفون: | Goodman J; MedImmune, Aaron Klug Building, Granta Park, Cambridge, Cambridgeshire, CB21 6GH, UK, +44 (0) 203 749 6244, +44 (0) 1223 471472., Cowen S; LGC, Queens Road, Teddington, Middlesex TW11 0LY, UK., Devanarayan V; Charles River Laboratories, 905 Sheehy Dr, Horsham, PA 19044; formerly located at Abbvie during the production of this manuscript., Egging D; Synthon, Microweg 22, P.O. Box 7071, 6503 GN Nijmegen, The Netherlands., Emrich T; Roche Pharma Research & Early Development, Roche Innovation Center Munich, Roche Diagnostics GmbH, Nonnenwald 2, 82377 Penzberg, Germany., Golob M; Nuvisan GmbH, Am Feld 32, 85567 Grafing, Germany., Kramer D; Sanofi Aventis Deutschland GmbH, Industriepark Höchst, D-Frankfurt am Main, Germany., McNally J; Shire, 300 Shire Way, Lexington MA 02421; formerly located at Merck Serono during production of this manuscript., Munday J; Covance Laboratories Ltd, Otley Road, Harrogate, HG31PY, United Kingdom., Nelson R; Novimmune SA, 14 Chemin des Aulx, 1228 Plan-les-Ouates, Geneva, Switzerland., Pedras-Vasconcelos JA; US Food and Drug Administration/Center for Drugs Evaluation and Research/Office of Biotechnology Products/Division of Biotech Review and Research 3, MD, USA., Piironen T; Syrinx Bioanalytics, Pansiontie 47, Biohouse D5, 20210 Turku, Finland., Sickert D; Novartis, Kohlenstrasse, WSJ-386.13.05.14, CH-4056 Basel, Switzerland., Skibeli V; Norwegian Medicines Agency, Stroemsveien 96, Postboks 6167 Etterstad, 0602 Oslo, Norway., Fjording MS; Novo Nordisk A/S, Novo Nordisk Park, DK-2760 Måløv, Denmark., Timmerman P; European Bioanalysis Forum, Havenlaan 86c b204, 1000 Brussels, Belgium. |
| المصدر: | Bioanalysis [Bioanalysis] 2018 Feb; Vol. 10 (4), pp. 197-204. Date of Electronic Publication: 2018 Jan 18. |
| نوع المنشور: | Congress |
| اللغة: | English |
| بيانات الدورية: | Publisher: Future Science Country of Publication: England NLM ID: 101512484 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1757-6199 (Electronic) Linking ISSN: 17576180 NLM ISO Abbreviation: Bioanalysis Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: London : Future Science, 2009- |
| مواضيع طبية MeSH: | Antibodies, Neutralizing/*analysis , Biological Products/*immunology , Drug Tolerance/*immunology , Immunoassay/*standards, Biological Products/therapeutic use ; Drug Discovery ; Guidelines as Topic ; Humans |
| مستخلص: | European Bioanalysis Forum Workshop, Lisbon, Portugal, September 2016: At the recent European Bioanalysis Forum Focus Workshop, 'current analysis of immunogenicity: best practices and regulatory hurdles', several important challenges facing the bioanalytical community in relation to immunogenicity assays were discussed through a mixture of presentations and panel sessions. The main areas of focus were the evolving regulatory landscape, challenges of assay interferences from either drug or target, cut-point setting and whether alternative assays can be used to replace neutralizing antibody assays. This workshop report captures discussions and potential solutions and/or recommendations made by the speakers and delegates. |
| فهرسة مساهمة: | Keywords: antidrug antibody (ADA); cut-point; drug tolerance; immunogenicity; neutralizing antibodies; regulatory guidance; target interference |
| المشرفين على المادة: | 0 (Antibodies, Neutralizing) 0 (Biological Products) |
| تواريخ الأحداث: | Date Created: 20180119 Date Completed: 20180802 Latest Revision: 20181202 |
| رمز التحديث: | 20221213 |
| DOI: | 10.4155/bio-2017-4971 |
| PMID: | 29345496 |
| قاعدة البيانات: | MEDLINE |
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