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

Joanne Goodmana Bioanalytical Services, Celerion, Lincoln, NE68502, USA
,
Kyra J Cowanb Merck KGaA, Research & Development, Drug Metabolism & Pharmacokinetics New Biological Entities, 64293, Darmstadt, Germany
,
Michaela Golobc Nuvisan GmbH, Bioanalysis, 89231, Neu-Ulm, Germany
,
Robert Nelsond BioAgilytix Laboratories, 22339, Hamburg, Germany
,
Daniel Baltrukonise Pfizer, Translational Clinical Sciences, Clinical Bioanalytics, Groton, CT06340, USA
,
Karien Bloemf Sanquin Diagnostic Services, R&D Antibodies & Immunogenicity, 1066 CX, Amsterdam, The Netherlands
,
Brendy Van Butselg Sanofi, Drug Metabolism & Pharmacokinetics, 9052, Zwijnaarde, Belgium
,
Lysie Championh Celerion Switzerland AG, Bioanalytical Services, 8320, Fehraltorf, Switzerland
,
John Cooki Charles River Laboratories Edinburgh, Department of Immunology, Bioanalysis & Biomarkers, EH33 2NE, Edinburgh, UK
,
Minh Dangd BioAgilytix Laboratories, 22339, Hamburg, Germany
,
Desislava Galevaj Labcorp Early Drug Development Laboratories Limited, Immunology & Immunotoxicology, PE28 4HS, Alconbury, Huntingdon, UK
,
Davide Guerrierik Hexal AG (A Sandoz company), Clinical Development Biopharmaceuticals, D-83607, Holzkirchen, Germany
,
Gregor Jordanl Roche Pharma Research & Early Development (pRED), Pharmaceutical Sciences, Bioanalysis & Biomarkers, Roche Innovation Center Munich, Roche Diagnostics GmbH, Penzberg, 82377, Germany
,
Carsten Krantzm Novartis, BioMedical Research, Basel, Switzerland
,
Ching-Hai Lain Regeneron Pharmaceuticals, Bioanalytical Sciences, TarrytownNY10591, USA
,
Toralf Rocho CheckImmune GmbH, Soluble Factors, 13353, Berlin, Germany
,
Adriano Luis Soares de Sonzap Fresenius Kabi SwissBioSim GmbH, Clinical Development, Medical & Pharmacovigilance, 1262, Eysins, Switzerland
,
Lauren Stevensonq Immunologix Laboratories, Tampa, FL33634, USA
,
Luis Perez Tosarr Novo Nordisk A/S, Non-Clinical & Clinical Assay Sciences, GDDS, 2760, Måløv, Denmark
,
Foka Venemas Ardena Bioanalysis, 9403 AJ, Assen, The Netherlands
,
Hanna Widmaierc Nuvisan GmbH, Bioanalysis, 89231, Neu-Ulm, Germany
&
Philip Timmermant European Bioanalysis Forum vzw (EBF), Havenlaan 86c b204, 1000, Brussels, BelgiumCorrespondence[email protected]
 show all
Received 26 Jun 2024, Accepted 03 Jul 2024, Published online: 09 Aug 2024

Figures & data

Figure 1. Tiered Approach for Clinical Immunogenicity Assessment.

Adapted from EMA Guidelines [Citation8].

Figure 1. Tiered Approach for Clinical Immunogenicity Assessment.Adapted from EMA Guidelines [Citation8].

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