The European Bioanalysis Forum recommendation on establishing appropriate drug tolerance levels in antidrug antibody assays-Reference-Cited by-同舟云学术

The European Bioanalysis Forum recommendation on establishing appropriate drug tolerance levels in antidrug antibody assays

Published:2024-08-05 Issue: Volume: Page:1-7
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Cowan Kyra J¹,Champion Lysie²,Dyer Daniel³,Carlsen Morten Funch⁴,Geary Laura⁵,Genin Jean-Christophe⁶,Golob Michaela⁷,Goodman Joanne⁸⁹,Kromminga Arno¹⁰,Nelson Rob¹¹,Revell Heather³,Rieger Martin¹²,de Vyver Ortwin Van¹³,Venema Foka¹⁴,Timmerman Philip¹⁵

Affiliation:

1. Merck KGaA, Research & Development, Drug Metabolism & Pharmacokinetics New Biological Entities, Darmstadt, 64293, Germany

2. Celerion Switzerland AG, Bioanalytical Services, Fehraltorf, 8320, Switzerland

3. Labcorp, Immunochemistry Method Development, Harrogate, HG3 1PY, UK

4. LEO Pharma, Bioanalysis & Pharmacokinetics, Ballerup, 2750, Denmark

5. Resolian Bioanalytics, Immunoassay Bioanalysis, Fordham, CB7 5WW, UK

6. F. Hoffmann-La Roche Ltd (Roche Innovation Center Basel), Basel, 4058, Switzerland

7. Nuvisan GmbH, Bioanalysis, Neu-Ulm, 89231, Germany

8. Bioanalytical Services, Celerion, Lincoln, NE 68502, USA

9. AstraZeneca, Cambridge, CB21 6GH, United Kingdom

10. Biolytics, BioNTech SE, Mainz, 55131, Germany

11. BioAgilytix Laboratories, Hamburg, 22339, Germany

12. MorphoSys AG, Clinical Pharmacology, Planegg, 82152, Germany

13. Sanofi, Drug Metabolism & Pharmacokinetics, Zwijnaarde, 9052, Belgium

14. Ardena Bioanalysis, AJ Assen, 9403, The Netherlands

15. European Bioanalysis Forum vzw (EBF), Havenlaan 86c b204, Brussels, 1000, Belgium

Publisher

Informa UK Limited

Link

https://www.tandfonline.com/doi/pdf/10.1080/17576180.2024.2376950

Reference43 articles.

1. Approaches to Mitigate the Unwanted Immunogenicity of Therapeutic Proteins during Drug Development

2. United States Food and Drug Administration. Immunogenicity testing of therapeutic protein products - developing and validating assays for anti-drug antibody detection. Guidance for Industry [Internet]. Washington, DC; 2019. Available from: https://www.fda.gov/media/119788/download

3. European Medicines Agency: Guideline on immunogenicity assessment of therapeutic proteins [Internet]. EMEA/CHMP/BMWP/14327/2006 Rev 1 [Internet]. London, UK; 2017. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-immunogenicity-assessment-therapeutic-proteins-revision-1_en.pdf

4. National Medical Products Association: Notice of CDE of China NMPA on issuing the technical guidance for immunogenicity studies of drugs [Internet]. Beijing China; 2021. Available from: https://english.nmpa.gov.cn/2021-03/30/c_654814.htm

5. Pharmaceuticals and Medical Devices Agency: Request for comments on the draft “Guidelines for Immunogenicity Assessment of Biopharmaceuticals” [Internet]. Tokyo Japan; 2024. Available from: https://public-comment.e-gov.go.jp/servlet/Public?CLASSNAME=PCMMSTDETAIL&id=495230372&Mode=0