Editor’s highlights from the European Bioanalysis Forum 2025
Tuning in to tomorrow: science in high definition
The European Bioanalysis Forum (EBF) Open Symposium is known for its thematic focus, and this year’s 2025 theme, ‘Tune into Tomorrow: Science in High Definition’, celebrated 100 years since the invention of the television. Browse our Editor’s highlights from the event below.
Welcome to the 18th Open Symposium
Speaker: Philip Timmerman, EBF
The Open Symposium began with a reflection on the eras of bioanalysis and what the term ‘bioanalysis’ has been used for over time. In the pioneering era (1980s), bioanalysis had just emerged from analytical chemistry, toxicology and clinical pharmacology and was slowly forming its own identity. This era was dominated by small molecules and GC and (HP)LC were the key tools in use. In the 1990s, craft became science and the bioanalytical portfolio expanded with new chemical entity generics and early biotech. The regulatory era (2000s) was characterized by the continued dominance of small molecules, alongside the rise of LC–MS and LBA technologies. In the harmonization era of the 2010s, the portfolio diversified with biologics and biomarkers, and the scientific and operational scope of bioanalysis expanded. LC–MS and LBA dominated, and other tech began knocking on the door. The innovation era (2020s) brought a wave of complex new modalities, forcing bioanalysis to stretch beyond its traditional boundaries. Philip emphasized how each era has shaped the skill sets of bioanalysts, with today’s professionals expected to meet increasingly diverse and sophisticated demands.
Embedding context in biomarker assays: practical implementation of context of use through case studies that highlight its impact and relevance
Speaker: Pratiksha Gulati, Strategy Area Leader
F. Hoffmann-La Roche (Basel, Switzerland)
Pratiksha’s presentation focused on the evolving role of biomarkers in modern drug development, emphasizing that a ‘one-size-fits-all’ approach is no longer viable. She reminded the audience that the purpose of a biomarker is not ‘static’ and can change throughout a project’s lifecycle, but how do we manage this evolving biomarker purpose? To address this, Pratiksha guided us through the steps her team uses, beginning with a focus on the stakeholders. The process begins with aligning clinical needs with analytical capabilities by engaging stakeholders early in the project. The second step involves collecting and documenting information using a ‘living’ document (the Biomarker Request Form) to track any updates during the project. The third step is the formulation of the analytical strategy, followed by formalizing the biomarker’s context of use (CoU) via a CoU statement. Validation and reporting occur in step five and the final step integrates biomarker data into clinical documentation. Pratiksha also presented two case studies demonstrating that a single validated biomarker assay cannot serve all clinical contexts, but a CoU-driven approach ensures biomarker methods are tailored to address specific, biologically relevant questions, enabling more informed decision making in clinical development.
Further listening: Exploring Biomarker Testing in Clinical Research
Podcast: PCR-based methods for gene therapy bioanalysis
We spoke to Katherine Veirs, Group Leader for translational medicine at QPS Holdings, LLC, about PCR methods for gene therapy bioanalysis. Sign up to get early access to this 3-part series here.
One tier, many truths: bringing a biomarker mindset to immunogenicity analysis
Lauren Stevenson, Chief Scientific Officer
Immunologix Laboratories (FL, USA)
Rethinking the immunogenicity testing paradigm has been a hotly debated topic in recent years and there have been numerous presentations and publications questioning the utility of the current three-tiered approach, including this session from PharmSci 360 2023. The current approach was born out of one specific high-risk case, which resulted in mandatory blanket immunogenicity testing and despite agreement amongst a large portion of the bioanalysis community that this paradigm is outdated, there remains hesitancy surrounding single-tiered analysis.
Lauren began her presentation with a ‘newsflash’ statement: it’s all biomarkers! Immunogenicity is a biological response to a therapeutic intervention and therefore should be treated as a biomarker. She went on to highlight case examples demonstrating how single-tiered analysis can provide greater clarity for clinical interpretation of immunogenicity that supports multiple CoU and proposed assay validation and data analysis approaches to support implementation.
Singlicate performance in Olink Target 48 panels
Speaker: Maria Janeh, Head of Quality Control
TATAA Biocenter (Gothenburg, Sweden)
Affinity-based proteomics platforms are increasingly being used in bioanalytical workflows to enable multiplex quantification of inflammation-related protein biomarkers. In her talk, Maria introduced the Olink Target 48 Cytokine panel, a dual recognition immunoassay, merging antibody-based immunoassay with PCR, which allows the simultaneous measurement of 45 human cytokines. She presented the repeated measurements and the impact of bridge normalization versus singlicate analysis on data quality, showing that the dual strategy of using bridging samples does not significantly improve technical consistency. Singlicate analysis demonstrated sufficient reproducibility and robustness, supporting the recommendation for Olink’s use for singlicate workflows.
Is MS imaging ready for prime time in DMPK studies?
Speaker: Neil Walsh, Director, Pharma Program Lead
Waters Corporation (MA, USA)
Presented on behalf of Neil Walsh by X, this talk discussed mass spectrometry imaging (MSI) as a tool for tissue distribution studies, amongst approaches such as whole body autoradiography and tissue extraction for LC–MS/MS, via QqQ and HRMS. But, as the title suggests, X probed the question of whether MSI is able to detect metabolites in tissues and organs at physiologically relevant drug levels. X ran through a Desorption Electrospray Ionization (DESI-) MS tissue imaging workflow, which has shown promise for drug detection and visualization in tissues with minimal sample pre-treatment and presented two case studies. Overall, X concluded that MSI does show strong potential for DMPK studies and enables spatially resolved, multiplexed analysis of drugs and metabolites in tissues. It offers complementary insights to traditional LC–MS workflows, enhancing understanding of drug distribution, metabolism and clearance.
You may also be interested in:
In the Zone: Targeted MS Imaging for Molecular Spatial Information
Read our In the Zone feature, in association with Waters Corporation, covering the key aspects of MSI and how the Waters Xevo™ TQ Absolute XR, coupled with the DESI™ XS targeted MSI solution, can address challenges in molecular visualization by offering unique, favorable features.
Missed an event in 2025? View our collection of conference reports to catch up on the discussions.
