Health AI Central
Peer-Reviewed Publication
Bioanalysis2026;1-7.October 18, 2026Journal Article

European Bioanalysis Forum cross-industry perspective on emerging small-molecule modalities: bioanalytical challenges and potential mitigation strategies.

Luca Ferrari1, Cecilia Arfvidsson2, Alessandro Greco3, Joerg Pausch4, Elaine Corcoran5, Kristi House6, Daniel Mascher7, Daniel Schulz-Jander8, Sonja Neitzel9, Christian Heinlein9, Tobias Klaassen10, Simon Beuck11, Amanda Wilson12, Heike Wiese13, Michael Blackburn14, Stephanie Keane15, Rebecca Paterson16, Connor Walker17, Johanna Paris18, Daniel Neddermann19, Daniel Villalba20, Emmanuel Njumbe Ediage21, Philip Timmerman22
1Roche Pharma Research & Early Development (pRED), F. Hoffmann-La Roche Ltd., Basel, Switzerland.
2Integrated Bioanalysis, Clinical Pharmacology & Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
3ADMET & Bioanalytical Sciences, Aptuit (Verona) Srl, An Evotec Company, Verona, Italy.
4Bioanalytics, BioNTech, Mainz, Germany.
5Intertek Pharmaceutical Services Manchester, Manchester, UK.
6Bioanalysis, Lablytica Life Science AB, Uppsala, Sweden.
7Bioanalysis, pharm-analyt Labor GmbH, Baden, Austria.
8Bioanalysis (Mass Spectrometry), QPS Netherlands BV, Groningen, The Netherlands.
9Bioanalytics, Axolabs GmbH, Kulmbach, Germany.
10A & M Labor für Analytik und Metabolismusforschung Service GmbH, Bergheim, Germany.
11Pharmaceuticals, Bioanalytics, Bayer AG, Wuppertal, Germany.
12Bioanalytical Services, Labcorp, Harrogate, UK.
13Bioanalysis, Nuvisan GmbH, Neu-Ulm, Germany.
14Bioanalytical Services, Arcinova, A Quotient Sciences Company, Alnwick, UK.
15Bioanalytics, Resolian, Fordham, UK.
16Chromatographic Bioanalysis, Charles River Laboratories, Edinburgh, UK.
17Roche Pharma Research and Early Development, Roche Innovation Center Welwyn, Welwyn Garden City, UK.
18Translational Medicine Unit, Sanofi, Montpellier, France.
19PK Sciences/Translational Medicine, Novartis, Basel, Switzerland.
20Bioanalysis, Biomarkers and Immunogenicity, Novo Nordisk US R&D, Boston, MA, USA.
21Bioanalytical Discovery and Development Sciences, Johnson and Johnson Innovative Medicine, Beerse, Belgium.
22European Bioanalysis Forum Vzw, Brussels, Belgium.
PubMed DOI

Abstract

Emerging small molecule modalities, including oligonucleotides, peptides, lipid nanoparticles, covalent inhibitors and prodrugs, challenge conventional bioanalytical approaches. Recognizing this, the European Bioanalysis Forum convened a cross-industry working group to systematically identify and categorize bioanalytical challenges across seven modality types. Recurring issues include instability,…

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