Feedback from the European Bioanalysis Forum: focus workshop on current analysis of immunogenicity: best practices and regulatory hurdles-Reference-Cited by-同舟云学术

Feedback from the European Bioanalysis Forum: focus workshop on current analysis of immunogenicity: best practices and regulatory hurdles

Published:2018-02 Issue:4 Volume:10 Page:197-204
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Goodman Joanne¹,Cowen Simon²,Devanarayan Viswanath³,Egging David⁴,Emrich Thomas⁵,Golob Michaela⁶,Kramer Daniel⁷,McNally Jim⁸,Munday James⁹,Nelson Robert¹⁰,Pedras-Vasconcelos João A¹¹,Piironen Timo¹²,Sickert Denise¹³,Skibeli Venke¹⁴,Fjording Marianne Scheel¹⁵,Timmerman Philip¹⁶

Affiliation:

1. MedImmune, Aaron Klug Building, Granta Park, Cambridge, Cambridgeshire, CB21 6GH, UK, +44 (0) 203 749 6244, +44 (0) 1223 471472

2. LGC, Queens Road, Teddington, Middlesex TW11 0LY, UK

3. Charles River Laboratories, 905 Sheehy Dr, Horsham, PA 19044; formerly located at Abbvie during the production of this manuscript

4. Synthon, Microweg 22, P.O. Box 7071, 6503 GN Nijmegen, The Netherlands

5. Roche Pharma Research & Early Development, Roche Innovation Center Munich, Roche Diagnostics GmbH, Nonnenwald 2, 82377 Penzberg, Germany

6. Nuvisan GmbH, Am Feld 32, 85567 Grafing, Germany

7. Sanofi Aventis Deutschland GmbH, Industriepark Höchst, D-Frankfurt am Main, Germany

8. Shire, 300 Shire Way, Lexington MA 02421; formerly located at Merck Serono during production of this manuscript

9. Covance Laboratories Ltd, Otley Road, Harrogate, HG31PY, United Kingdom

10. Novimmune SA, 14 Chemin des Aulx, 1228 Plan-les-Ouates, Geneva, Switzerland

11. US Food and Drug Administration/Center for Drugs Evaluation and Research/Office of Biotechnology Products/Division of Biotech Review and Research 3, MD, USA

12. Syrinx Bioanalytics, Pansiontie 47, Biohouse D5, 20210 Turku, Finland

13. Novartis, Kohlenstrasse, WSJ-386.13.05.14, CH-4056 Basel, Switzerland

14. Norwegian Medicines Agency, Stroemsveien 96, Postboks 6167 Etterstad, 0602 Oslo, Norway

15. Novo Nordisk A/S, Novo Nordisk Park, DK-2760 Måløv, Denmark

16. European Bioanalysis Forum, Havenlaan 86c b204, 1000 Brussels, Belgium

Abstract

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.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Link

http://www.future-science.com/doi/pdf/10.4155/bio-2017-4971

Reference15 articles.

1. European Bioanalysis Forum. www.europeanbioanalysisforum.eu/.

2. European Medicines Agency. Guideline on Immunogenicity Assessment of Biotechnology-Derived Therapeutic Proteins. EMEA/CHMP/BMWP/14327/2006 Rev. 1. 24 September 2015. www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/10/WC500194507.pdf.

3. US FDA. Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products (Draft Guidance) (2016). www.fda.gov/downloads/Drugs/Guidances/UCM192750.pdf.

4. EBF recommendation for stability testing of anti-drug antibodies; lessons learned from anti-vaccine antibody stability studies

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