Fit-for-purpose application of LC-MS in protein bioanalysis, case studies shared within the European Bioanalysis...

The use of liquid chromatography-mass spectrometry for quantitative large-molecule bioanalysis has increased substantially over the past decade, driven by its ability to address analytical challenges that may be difficult to resolve using traditional ligand-binding assays. In this European Bioanalysis Forum perspective, seven case studies from pharmaceutical companies and contract research organizations illustrate the fit-for-purpose application of LC-MS across different stages of drug development. These include isoform-specific quantification, subclass-resolved immunoglobulin profiling, characterization of post-translational modifications, assessment of in vivo biotherapeutic integrity, and multiplexed analysis in complex biological matrices. Collectively, the examples highlight how LC-MS can support selectivity, structural insight, and analytical flexibility when aligned with the specific context of use. The EBF aims to foster continued scientific exchange by encouraging the sharing of such case studies across its community.