European Bioanalysis Forum cross-industry perspective on emerging small-molecule modalities: bioanalytical challenges and potential mitigation strategies
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, poor recovery, matrix effects and anti-drug antibody interference. Beyond documenting these challenges, the group collected preliminary mitigation strategies based on cross-company experience and scientific discussion. These strategies represent potential approaches rather than formal recommendations. The findings highlight that emerging modalities require early cross-functional assessment and modality-specific analytical strategies, guided by the intended use of the data. This initial categorization provides a foundation for further scientific evaluation, community alignment and regulatory dialogue, supporting the development of science-driven, fit-for-purpose bioanalytical approaches as experience with these modalities evolves.
