Evidence map›Paper›PMID 39506372›Full record

ArticleBioanalysis2025

Perspective on LC-MS(/MS) for biotherapeutic and biomarker proteins in research and regulated Bioanalysis: a consolidation of more than a decade of experience across the European Bioanalysis Forum community (Part 2: "The How").

Nico van de Merbel, Mark Jean Gnoth, Amanda Wilson, Peter Blattmann, Benno Ingelse, Gregor Jordan, Fabrizia Fusetti, Michael Blackburn, Sune Hove Sporring, Iain Love and 4 more

Abstract read
In one paragraph

Article in Bioanalysis, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Nico van de MerbelICON, Bioanalytical Laboratories, 9407, TK Assen, the Netherlands.
Mark Jean GnothBayer, DMPK, in vivo PK and bioanalytics, Bayer AG, 42096, Wuppertal, Germany.
Amanda WilsonLabcorp Early Development Laboratories Limited, Bioanalytical Services Harrogate, HG3 1PY, United Kingdom employed by AstraZeneca, Cambridge, CB21 6GH, United Kingdom during the writing of the manuscript.
Peter BlattmannIdorsia Pharmaceuticals Ltd, Translational Sciences, 4123, Allschwil, Switzerland.
Benno IngelseByondis B.V., Department of Bioanalysis & Protein Interaction, 6545, CM Nijmegen, the Netherlands.
Gregor JordanRoche Pharma Research & Early Development (pRED), Pharmaceutical Sciences, Bioanalytics & Biomarkers, Roche Innovation Center Munich, Roche Diagnostics GmbH, Penzberg, 82377, Germany.
Fabrizia FusettiGenmab b.v., Non-Clinical Bioanalytical Science, 3584, CT Utrecht, the Netherlands.
Michael BlackburnQuotient Sciences, Bioanalytical Services, Taylor Drive, Alnwick, Northumberland, NE66 2DH, United Kingdom.
Sune Hove SporringNovo Nordisk, LCMS Bioanalysis, Novo Nordisk Park, DK-3500, Maloev, Denmark.
Iain LoveCharles River Laboratories Edinburgh Limited, Department of Chromatographic Bioanalysis, Tranent, East Lothian, EH33 2NE, United Kingdom.
Stephane MuccioSanofi, Biomarkers & Clinical Bioanalyses (BCB), Translational Medicine and Early Development (TMED), 34184, Montpellier, France.
Matthew BarfieldRoche Innovation Center Welwyn, Roche Pharma Research and Early Development, Welwyn Garden City, AL7 1TW, Hertfordshire, United Kingdom.
Rob WhellerResolian, Bioanalytics, Newmarket Road, Fordham, CB7 5WW, United Kingdom.
Philip TimmermanEuropean Bioanalysis Forum, Havenlaan 86c b204, 1000, Brussels, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Following up on our most recent discussion paper focussing on the continued regulatory challenges for bioanalysis of biotherapeutic and biomarker proteins with LC-MS/MS, the European Bioanalysis Forum reports back on their internal discussions on and experience with method development for biotherapeutic and biomarker proteins in research and regulated Bioanalysis. Due to the broad array of topics discussed, this information is spread over two research papers, where one focusses on the fundamental principles on which the technology is built (i.e., the what) and another on the practical considerations (i.e., the how). In this paper, we discuss 'the how'. Both papers should be helpful for the bioanalytical community to better understand the challenges and provide an insight on why bioanalysis of biotherapeutic and biomarker proteins with LC-MS/MS should not be compared with the more traditional LC-MS/MS assay for small molecules or ligand binding assays for biotherapeutics.

Indexed as

BiomarkersProteinsTandem Mass SpectrometryChromatography, LiquidEuropeHumansLiquid Chromatography-Mass SpectrometryBiomarkersProteinsbest practicesbiotherapeuticsEuropean Bioanalysis Forumhybrid assaysLC-MS(/MS)regulationsscientific rigor

Identifiers

PMID39506372
PMCPMC11801336

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.