Recommendations and discussion points on immunogenicity, biomarkers, automation/technology and protein-MS from the 2021 European Bioanalysis Forum Focus Workshops.

Autor:	Timmerman P; European Bioanalysis Forum, 1000, Brussels, Belgium., Barfield M; Roche Pharma Research & Early Development, Pharmaceutical Sciences, Roche Innovation Center Basel, F Hoffmann-La Roche Ltd, 4070, Basel, Switzerland., Cowan K; Merck KGaA, New Biological Entities Drug Metabolism & Pharmacokinetics, 64293, Darmstadt, Germany., Golob M; Nuvisan GmbH, Bioanalysis, 89231, Neu-Ulm, Germany., Goodman J; Integrated Bioanalysis, Clinical Pharmacology & Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, CB21 6GH, UK., Kunz U; Boehringer Ingelheim Pharma GmbH & Co. KG, Translational Medicine & Clinical Pharmacology, 88400, Biberach ad Riss, Germany., Laurén A; Non-clinical & Clinical Assay Sciences, Global Discovery & Development Sciences, Global Drug Discovery, Novo Nordisk A/S, DK-2760, Måløv, Denmark., Love I; Charles River Laboratories, Department of Chromatographic Bioanalysis, EH33 2NE, Edinburgh, UK., Nelson R; Labcorp Drug Development, Scientific Affairs, 1217, Meyrin, Switzerland., Staack RF; Roche Pharma Research & Early Development, Pharmaceutical Sciences, Roche Innovation Center Munich, Roche Diagnostics GmbH, 82377, Penzberg, Germany., Stanta J; Freeline Therapeutics, Stevenage Bioscience Catalyst, Gunnels Wood Road, Stevenage, SG1 2FX, UK., van de Merbel N; Icon, Bioanalytical Laboratory, 9407, TK, Assen, The Netherlands., Wilson A; Integrated Bioanalysis, Clinical Pharmacology & Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, CB22 3AT, UK.
Jazyk:	angličtina
Zdroj:	Bioanalysis [Bioanalysis] 2021 Oct; Vol. 13 (19), pp. 1459-1465. Date of Electronic Publication: 2021 Oct 04.
DOI:	10.4155/bio-2021-0200
Abstrakt:	During the first half of 2021, and due to the SARS-CoV-2 pandemic preventing in-person meetings, the European Bioanalysis Forum organized four workshops as live interactive online meetings. The themes discussed at the workshops were carefully selected to match the cyberspace dynamics of the meeting format. The first workshop was a training day on challenges related to immunogenicity. The second one focused on biomarkers and continued the important discussion on integrating the principles of Context of Use (CoU) in biomarker research. The third workshop was dedicated to technology, that is, cutting-edge development in cell-based and ligand-binding assays and automation strategies. The fourth was on progress and the continued scientific and regulatory challenges related to peptide and protein analysis with MS. In all four workshops, the European Bioanalysis Forum included a mixture of scientific and regulatory themes, while reminding the audience of important strategic aspects and our responsibility toward the patient.
Databáze:	MEDLINE
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