Immunogenicity risk assessment for tailored mitigation and monitoring of biotherapeutics during development: recommendations from the European Immunogenicity Platform.
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| Title: | Immunogenicity risk assessment for tailored mitigation and monitoring of biotherapeutics during development: recommendations from the European Immunogenicity Platform. |
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| Authors: | Grudzinska-Goebel J; Preclinical Development, Pharmaceuticals R&D, Bayer AG, Berlin, Germany., Benstein K; Translational Medicine Unit, Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany., Bloem K; R&D Antibodies and Immunogenicity, Pharma and Biotech Services, Sanquin Diagnostic Services, Amsterdam, Netherlands., Cowan KJ; Drug Metabolism and Pharmacokinetics, New Biological Entities, Research and Development, Merck KGaA, Darmstadt, Germany., Gorovits B; Bioanalytical Sciences, Regeneron Pharmaceuticals Inc., Tarrytown, NY, United States., Jadhav M; Pharmacokinetic Sciences - Drug Disposition, Biomedical Research, Novartis, Cambridge, MA, United States., Janssen M; SciPot Consultancy B.V, Amsterdam, Netherlands., Jawa V; Translational Medicine, Bristol Myers Squibb, Lawrenceville, NJ, United States., Kiessling A; Precliclinical Safety, Biomedical Research, Novartis, Basel, Switzerland., Kramer D; Translational Medicine Unit, Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany., Kromminga A; Biolytics, BioNTech SE, Mainz, Germany.; Kromminga Consulting, Hamburg, Germany., van der Linden M; Bioanalytical Science, Genmab B.V., Utrecht, Netherlands., Liu S; Translational Clinical Sciences, Biologics & Immunogenicity, Clinical Bioanalytics, Pfizer, Vaughan, ON, Canada., Lotz GP; Roche Pharmaceutical Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center Munich, Penzberg, Germany., Luo L; Regulated Bioanalytics, Merck & Co., Inc., Rahway, NJ, United States., Malisauskas M; Non-Clinical Safety Research, H. Lundbeck A/S, Valby, Denmark., Marban-Doran C; Roche Pharmaceutical Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center Basel, Basel, Switzerland., Mytych DT; Clinical Immunology Department, Clinical Development, Amgen, Inc., Thousand Oaks, CA, United States., Oquendo Cifuentes E; Drug Metabolism and Pharmacokinetics, Boehringer-Ingelheim Pharmaceuticals Inc, Ridgefield, CT, United States., Pippig S; Scientific Affairs, Formycon, Martinsried, Germany., Ribes S; Global Clinical Development, Hexal AG (a Sandoz company), Holzkirchen, Germany., Rouwette M; Bioanalysis & Protein Interaction Department, Byondis B.V., Nijmegen, Netherlands., Shao W; Integrated Bioanalysis, Clinical Pharmacology and Safety Sciences, AstraZeneca, Gaithersburg, MD, United States., Tourdot S; Pharmacokinetics, Dynamics and Metabolism, Pfizer Inc., Andover, MA, United States., Weldingh KN; Non-Clinical and Clinical Assay Sciences, Novo Nordisk A/S, Måløv, Denmark., Snoeck V; Precision Medicine, Early Clinical Development & Translational Science, UCB, Braine-l'Alleud, Belgium. |
| Source: | Frontiers in immunology [Front Immunol] 2025 May 22; Vol. 16, pp. 1581153. Date of Electronic Publication: 2025 May 22 (Print Publication: 2025). |
| Publication Type: | Journal Article; Review |
| Journal Info: | Publisher: Frontiers Research Foundation] Country of Publication: Switzerland NLM ID: 101560960 Publication Model: eCollection Cited Medium: Internet ISSN: 1664-3224 (Electronic) Linking ISSN: 16643224 NLM ISO Abbreviation: Front Immunol Subsets: MEDLINE |
| Database: | MEDLINE Ultimate |
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| ISSN: | 1664-3224 |
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| DOI: | 10.3389/fimmu.2025.1581153 |
