Evidence map›Paper›PMID 40916631›Full record

ArticleElectrophoresis2025

The Hidden Influence: Impacts of Residual Dimethylformamide in NDSB-211 on icIEF Separation for Monoclonal Antibodies.

Delaney Doran, Matthew Myers, Katarina Moravcevic, Steven LaBrenz, Pinger Wang, Xiaoying Ji

Abstract read
In one paragraph

Article in Electrophoresis, 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

6 authors.

Delaney DoranTherapeutics Development and Supply-Analytical Development, Janssen Research & Development, LLC, Malvern, Pennsylvania, USA.
Matthew MyersTherapeutics Development and Supply-Analytical Development, Janssen Research & Development, LLC, Malvern, Pennsylvania, USA.
Katarina MoravcevicTherapeutics Development and Supply-Analytical Development, Janssen Research & Development, LLC, Malvern, Pennsylvania, USA.
Steven LaBrenzTherapeutics Development and Supply-Analytical Development, Janssen Research & Development, LLC, Malvern, Pennsylvania, USA.
Pinger WangTherapeutics Development and Supply-Analytical Development, Janssen Research & Development, LLC, Malvern, Pennsylvania, USA.
Xiaoying JiTherapeutics Development and Supply-Analytical Development, Janssen Research & Development, LLC, Malvern, Pennsylvania, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Monoclonal antibodies (mAbs) present analytical challenges due to their inherent heterogeneity and susceptibility to post-translational modifications (PTMs) during production and storage. Monitoring of charge heterogeneity profiles by imaged capillary isoelectric focusing (icIEF) has been aided by the use of non-detergent sulfobetaines (NDSBs), particularly NDSB-211, to enhance protein solubility and stability. When used in a quality control laboratory setting, NDSB-211 has shown performance variability over time due to residual manufacturing impurities that impact the capillary isoelectric focusing separation. Dimethylformamide (DMF) was detected using

Indexed as

Antibodies, MonoclonalDimethylformamideCapillary Isoelectric FocusingElectrophoresis, CapillaryIsoelectric FocusingAntibodies, MonoclonalDimethylformamidecharge heterogeneity | imaged capillary isoelectric focusing | monoclonal antibody | non‐detergent sulfobetaine (NDSB)‐211

Identifiers

PMID40916631
PMCPMC12572698

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.