Evidence map›Paper›PMID 40200843›Full record

ArticleBioanalysis2025

Recent discussions and proposals on challenging the 3-tier immunogenicity testing strategies from the European bioanalysis forum.

Kyra J Cowan, Karien Bloem, Annelies Coddens, Laura Creed, Hannah Higgins, Jonathan Jimenez Novoa, Christopher Jones, Yvonne Katterle, Marco Klinge, Ben Leatherdale and 6 more

Abstract read
PubMed Full text at PMC Publisher
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 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. 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

16 authors.

Kyra J CowanResearch and Development, Drug Metabolism and Pharmacokinetics New Biological Entities, Merck KGaA, Darmstadt, Germany.
Karien BloemR&D Antibodies and Immunogenicity, Sanquin Diagnostic Services, Amsterdam, The Netherlands.
Annelies CoddensBioanalytics, argenx BV, Zwijnaarde, Belgium.
Laura CreedResolian Bioanalytics, Fordham, UK.
Hannah HigginsBioanalysis (Large Molecule), Labcorp, Harrogate, UK.
Jonathan Jimenez NovoaBioanalysis (Large Molecule), Labcorp, Harrogate, UK.
Christopher JonesIntegrated Bioanalysis, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK.
Yvonne KatterleDMPK, in vivo PK and bioanalytics, Bayer, Bayer AG, Wuppertal, Germany.
Marco KlingeBioAgilytix Laboratories, Hamburg, Germany.
Ben LeatherdaleBioanalytical, ADC Therapeutics, London, UK.
Birgit JaitnerNovartis Pharma AG, BioMedical Research, Pharmacokinetic Sciences, Novartis Pharma AG, Basel, Switzerland.
Peter van BommelBioanalytical Laboratories, ICON, Assen, the Netherlands.
Saskia van der LeeICON, Bioanalytical Science, Genmab BV, Utrecht, the Netherlands.
Michaela GolobBioanalysis, Nuvisan GmbH, Neu-Ulm, Germany.
Rob NelsonBioAgilytix Laboratories, Hamburg, Germany.
Philip TimmermanEuropean Bioanalysis Forum vzw, Brussels, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The European Bioanalysis Forum, in discussions with cross-industry experts from pharmaceutical, biotech, and contract research organizations, is continuing the challenge of the traditional 3-Tier immunogenicity testing strategy, proposing a simpler, context-driven 1-Tier approach, a recent paradigm shift that emphasizes clinical relevance and the impact of anti-drug antibodies over mere incidence. In a workshop at the 17

Indexed as

AntibodiesEuropeHumansAntibodies1-Tierimmunogenicity testing strategyindustry challenge

Identifiers

PMID40200843
PMCPMC12128674

What Socratic 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 Socratic graph.