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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| Header | DbId: mdl DbLabel: MEDLINE Ultimate An: 40475758 AccessLevel: 2 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: Immunogenicity risk assessment for tailored mitigation and monitoring of biotherapeutics during development: recommendations from the European Immunogenicity Platform. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AU" term="%22Grudzinska-Goebel+J%22">Grudzinska-Goebel J</searchLink>; Preclinical Development, Pharmaceuticals R&D, Bayer AG, Berlin, Germany.<br /><searchLink fieldCode="AU" term="%22Benstein+K%22">Benstein K</searchLink>; Translational Medicine Unit, Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany.<br /><searchLink fieldCode="AU" term="%22Bloem+K%22">Bloem K</searchLink>; R&D Antibodies and Immunogenicity, Pharma and Biotech Services, Sanquin Diagnostic Services, Amsterdam, Netherlands.<br /><searchLink fieldCode="AU" term="%22Cowan+KJ%22">Cowan KJ</searchLink>; Drug Metabolism and Pharmacokinetics, New Biological Entities, Research and Development, Merck KGaA, Darmstadt, Germany.<br /><searchLink fieldCode="AU" term="%22Gorovits+B%22">Gorovits B</searchLink>; Bioanalytical Sciences, Regeneron Pharmaceuticals Inc., Tarrytown, NY, United States.<br /><searchLink fieldCode="AU" term="%22Jadhav+M%22">Jadhav M</searchLink>; Pharmacokinetic Sciences - Drug Disposition, Biomedical Research, Novartis, Cambridge, MA, United States.<br /><searchLink fieldCode="AU" term="%22Janssen+M%22">Janssen M</searchLink>; SciPot Consultancy B.V, Amsterdam, Netherlands.<br /><searchLink fieldCode="AU" term="%22Jawa+V%22">Jawa V</searchLink>; Translational Medicine, Bristol Myers Squibb, Lawrenceville, NJ, United States.<br /><searchLink fieldCode="AU" term="%22Kiessling+A%22">Kiessling A</searchLink>; Precliclinical Safety, Biomedical Research, Novartis, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Kramer+D%22">Kramer D</searchLink>; Translational Medicine Unit, Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany.<br /><searchLink fieldCode="AU" term="%22Kromminga+A%22">Kromminga A</searchLink>; Biolytics, BioNTech SE, Mainz, Germany.; Kromminga Consulting, Hamburg, Germany.<br /><searchLink fieldCode="AU" term="%22van+der+Linden+M%22">van der Linden M</searchLink>; Bioanalytical Science, Genmab B.V., Utrecht, Netherlands.<br /><searchLink fieldCode="AU" term="%22Liu+S%22">Liu S</searchLink>; Translational Clinical Sciences, Biologics & Immunogenicity, Clinical Bioanalytics, Pfizer, Vaughan, ON, Canada.<br /><searchLink fieldCode="AU" term="%22Lotz+GP%22">Lotz GP</searchLink>; Roche Pharmaceutical Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center Munich, Penzberg, Germany.<br /><searchLink fieldCode="AU" term="%22Luo+L%22">Luo L</searchLink>; Regulated Bioanalytics, Merck & Co., Inc., Rahway, NJ, United States.<br /><searchLink fieldCode="AU" term="%22Malisauskas+M%22">Malisauskas M</searchLink>; Non-Clinical Safety Research, H. Lundbeck A/S, Valby, Denmark.<br /><searchLink fieldCode="AU" term="%22Marban-Doran+C%22">Marban-Doran C</searchLink>; Roche Pharmaceutical Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center Basel, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Mytych+DT%22">Mytych DT</searchLink>; Clinical Immunology Department, Clinical Development, Amgen, Inc., Thousand Oaks, CA, United States.<br /><searchLink fieldCode="AU" term="%22Oquendo+Cifuentes+E%22">Oquendo Cifuentes E</searchLink>; Drug Metabolism and Pharmacokinetics, Boehringer-Ingelheim Pharmaceuticals Inc, Ridgefield, CT, United States.<br /><searchLink fieldCode="AU" term="%22Pippig+S%22">Pippig S</searchLink>; Scientific Affairs, Formycon, Martinsried, Germany.<br /><searchLink fieldCode="AU" term="%22Ribes+S%22">Ribes S</searchLink>; Global Clinical Development, Hexal AG (a Sandoz company), Holzkirchen, Germany.<br /><searchLink fieldCode="AU" term="%22Rouwette+M%22">Rouwette M</searchLink>; Bioanalysis & Protein Interaction Department, Byondis B.V., Nijmegen, Netherlands.<br /><searchLink fieldCode="AU" term="%22Shao+W%22">Shao W</searchLink>; Integrated Bioanalysis, Clinical Pharmacology and Safety Sciences, AstraZeneca, Gaithersburg, MD, United States.<br /><searchLink fieldCode="AU" term="%22Tourdot+S%22">Tourdot S</searchLink>; Pharmacokinetics, Dynamics and Metabolism, Pfizer Inc., Andover, MA, United States.<br /><searchLink fieldCode="AU" term="%22Weldingh+KN%22">Weldingh KN</searchLink>; Non-Clinical and Clinical Assay Sciences, Novo Nordisk A/S, Måløv, Denmark.<br /><searchLink fieldCode="AU" term="%22Snoeck+V%22">Snoeck V</searchLink>; Precision Medicine, Early Clinical Development & Translational Science, UCB, Braine-l'Alleud, Belgium. – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22101560960%22">Frontiers in immunology</searchLink> [Front Immunol] 2025 May 22; Vol. 16, pp. 1581153. <i>Date of Electronic Publication: </i>2025 May 22 (<i>Print Publication: </i>2025). – Name: TypePub Label: Publication Type Group: TypPub Data: Journal Article; Review – Name: TitleSource Label: Journal Info Group: Src Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Frontiers+Research+Foundation]%22">Frontiers Research Foundation] </searchLink><i>Country of Publication: </i>Switzerland <i>NLM ID: </i>101560960 <i>Publication Model: </i>eCollection <i>Cited Medium: </i>Internet <i>ISSN: </i>1664-3224 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2216643224%22">16643224 </searchLink><i>NLM ISO Abbreviation: </i>Front Immunol <i>Subsets: </i>MEDLINE |
| PLink | https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=mdl&AN=40475758 |
| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.3389/fimmu.2025.1581153 Languages: – Code: eng Text: English PhysicalDescription: Pagination: StartPage: 1581153 Titles: – TitleFull: Immunogenicity risk assessment for tailored mitigation and monitoring of biotherapeutics during development: recommendations from the European Immunogenicity Platform. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Grudzinska-Goebel J – PersonEntity: Name: NameFull: Benstein K – PersonEntity: Name: NameFull: Bloem K – PersonEntity: Name: NameFull: Cowan KJ – PersonEntity: Name: NameFull: Gorovits B – PersonEntity: Name: NameFull: Jadhav M – PersonEntity: Name: NameFull: Janssen M – PersonEntity: Name: NameFull: Jawa V – PersonEntity: Name: NameFull: Kiessling A – PersonEntity: Name: NameFull: Kramer D – PersonEntity: Name: NameFull: Kromminga A – PersonEntity: Name: NameFull: van der Linden M – PersonEntity: Name: NameFull: Liu S – PersonEntity: Name: NameFull: Lotz GP – PersonEntity: Name: NameFull: Luo L – PersonEntity: Name: NameFull: Malisauskas M – PersonEntity: Name: NameFull: Marban-Doran C – PersonEntity: Name: NameFull: Mytych DT – PersonEntity: Name: NameFull: Oquendo Cifuentes E – PersonEntity: Name: NameFull: Pippig S – PersonEntity: Name: NameFull: Ribes S – PersonEntity: Name: NameFull: Rouwette M – PersonEntity: Name: NameFull: Shao W – PersonEntity: Name: NameFull: Tourdot S – PersonEntity: Name: NameFull: Weldingh KN – PersonEntity: Name: NameFull: Snoeck V IsPartOfRelationships: – BibEntity: Dates: – D: 22 M: 05 Text: 2025 May 22 Type: published Y: 2025 Identifiers: – Type: issn-electronic Value: 1664-3224 Numbering: – Type: volume Value: 16 Titles: – TitleFull: Frontiers in immunology Type: main |
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