Re-thinking the current paradigm for clinical immunogenicity assessment: an update from the discussion in the European Bioanalysis Forum-Reference-Cited by-同舟云学术

Re-thinking the current paradigm for clinical immunogenicity assessment: an update from the discussion in the European Bioanalysis Forum

Published:2024-08-09 Issue: Volume: Page:1-9
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Goodman Joanne¹,Cowan Kyra J²,Golob Michaela³,Nelson Robert⁴,Baltrukonis Daniel⁵,Bloem Karien⁶,Butsel Brendy Van⁷,Champion Lysie⁸,Cook John⁹,Dang Minh⁴,Galeva Desislava¹⁰,Guerrieri Davide¹¹,Jordan Gregor¹²,Krantz Carsten¹³,Lai Ching-Hai¹⁴,Roch Toralf¹⁵,Soares de Sonza Adriano Luis¹⁶,Stevenson Lauren¹⁷,Tosar Luis Perez¹⁸,Venema Foka¹⁹,Widmaier Hanna³,Timmerman Philip²⁰

Affiliation:

1. Bioanalytical Services, Celerion, Lincoln, NE 68502, USA employed by AstraZeneca, Cambridge, CB21 6GH, United Kingdom during the writing of the manuscript

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

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

4. BioAgilytix Laboratories, 22339, Hamburg, Germany

5. Pfizer, Translational Clinical Sciences, Clinical Bioanalytics, Groton, CT 06340, USA

6. Sanquin Diagnostic Services, R&D Antibodies & Immunogenicity, 1066 CX, Amsterdam, The Netherlands

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

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

9. Charles River Laboratories Edinburgh, Department of Immunology, Bioanalysis & Biomarkers, EH33 2NE, Edinburgh, UK

10. Labcorp Early Drug Development Laboratories Limited, Immunology & Immunotoxicology, PE28 4HS, Alconbury, Huntingdon, UK

11. Hexal AG (A Sandoz company), Clinical Development Biopharmaceuticals, D-83607, Holzkirchen, Germany

12. Roche Pharma Research & Early Development (pRED), Pharmaceutical Sciences, Bioanalysis & Biomarkers, Roche Innovation Center Munich, Roche Diagnostics GmbH, Penzberg, 82377, Germany

13. Novartis, BioMedical Research, Basel, Switzerland

14. Regeneron Pharmaceuticals, Bioanalytical Sciences, Tarrytown NY 10591, USA

15. CheckImmune GmbH, Soluble Factors, 13353, Berlin, Germany

16. Fresenius Kabi SwissBioSim GmbH, Clinical Development, Medical & Pharmacovigilance, 1262, Eysins, Switzerland

17. Immunologix Laboratories, Tampa, FL 33634, USA

18. Novo Nordisk A/S, Non-Clinical & Clinical Assay Sciences, GDDS, 2760, Måløv, Denmark

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

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

Publisher

Informa UK Limited

Link

https://www.tandfonline.com/doi/pdf/10.1080/17576180.2024.2376949

Reference33 articles.

1. United States Food and Drug Administration: Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Labeling – Content and Format [Internet]. Washington DC; 2022. Available from: https://www.fda.gov/media/155871/download

2. Bergrem H, Danielson BG, Eckardt K-U, Kurtz A. Stridsberg M: a case of antierythropoietin antibodies following recombinant human erythropoietin treatment. In: Bauer C, Koch KM, Scigalla P, editors. Erythropoietin: Molecular Physiology and Clinical Application. New York (NY): Marcel Dekker; 1993. p. 266–275.

3. Antibodies against Recombinant Human Erythropoietin in a Patient with Erythropoietin-Resistant Anemia

4. Antibodies to recombinant human erythropoietin causing pure red cell aplasia;Prabhakar SS;Clin Nephrol.,1997

5. Pure Red-Cell Aplasia and Antierythropoietin Antibodies in Patients Treated with Recombinant Erythropoietin

Cited by 2 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. The European Bioanalysis Forum recommendation on establishing appropriate drug tolerance levels in antidrug antibody assays;Bioanalysis;2024-08-05

2. A European Bioanalysis Forum recommendation for requiring a context-of-use statement for successful development and validation of biomarker assays;Bioanalysis;2024-08-05