Evidence map›Paper›PMID 42745381›Full record

ArticlemAbs2026

A framework for evaluating unexpected reactions in antibody-drug conjugates during clinical development: a case study of a promiscuous payload.

Eef H C Dirksen, Marijn Buurman, Jeroen Kooistra, Benno Ingelse, Ruud Ubink

Abstract read
In one paragraph

Article in mAbs, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

5 authors.

Eef H C DirksenAnalytical Development and Quality Control, Byondis B.V., Nijmegen, The Netherlands.ORCID 0000-0002-5246-8604
Marijn BuurmanAnalytical Development and Quality Control, Byondis B.V., Nijmegen, The Netherlands.
Jeroen KooistraBioanalytics & DMPK, Byondis B.V., Nijmegen, The Netherlands.
Benno IngelseBioanalytics & DMPK, Byondis B.V., Nijmegen, The Netherlands.
Ruud UbinkBioanalytics & DMPK, Byondis B.V., Nijmegen, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Antibody-drug conjugates (ADCs) are complex biotherapeutic molecules, comprising an antibody moiety and a small molecule linker-drug. The product quality of an ADC is controlled through monitoring of critical quality attributes to ensure safety and efficacy. During development, unexpected changes may occur in the product quality of an ADC, for example under stress or physiological conditions. This should prompt a systematic evaluation to determine the cause and impact on product quality. A structured approach for such an evaluation is not well established. Here, a strategy for the detection, identification, and assessment of unexpected reactions in an ADC during clinical development is presented encompassing physicochemical and functional analytical characterization, mechanistic confirmation, and evaluation of the relevance

Indexed as

Antibodies, MonoclonalDrug DevelopmentImmunoconjugatesAnimalsHumansAntibodies, MonoclonalImmunoconjugatesAntibody-drug conjugatebioanalysiscritical quality attributecross-linkingframeworklinker-drugmass spectrometrypotency

Identifiers

PMID42745381
PMCPMC13596894

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.