Evidence map›Paper›PMID 40202920›Full record

ArticleMolecular pharmaceutics2025

Reduced IgG1 Antibody Left-Twisted Antiparallel β-Sheet Structure Stability Occurs under Metal-Catalyzed Oxidation Conditions in the Presence of Polysorbates.

Mari Lehtimaki, Uriel Ortega-Rodriguez, Garrick Centola, V Ashutosh Rao

Abstract read
In one paragraph

Article in Molecular pharmaceutics, 2025. 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

4 authors.

Mari LehtimakiLaboratory of Applied Biochemistry, Division of Biotechnology Research and Review III, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administrations, Silver Spring, Maryland 20993, United States.
Uriel Ortega-RodriguezLaboratory of Applied Biochemistry, Division of Biotechnology Research and Review III, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administrations, Silver Spring, Maryland 20993, United States.
Garrick CentolaLaboratory of Applied Biochemistry, Division of Biotechnology Research and Review III, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administrations, Silver Spring, Maryland 20993, United States.
V Ashutosh RaoLaboratory of Applied Biochemistry, Division of Biotechnology Research and Review III, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administrations, Silver Spring, Maryland 20993, United States.ORCID 0000-0001-6817-8049

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

Polysorbates are common surfactants in monoclonal antibody (mAb) drug products. While polysorbates assist in stabilizing and refolding proteins, oxidative stress conditions can reduce protein stability wherein polysorbate binds to the oxidized and unfolded protein. We investigated the effects of polysorbates on the higher-order structural stability of mAbs under oxidative conditions that may occur during manufacturing, storage, and use. Secondary and tertiary structures of trastuzumab and rituximab products were investigated under two oxidative conditions: metal-catalyzed oxidation (MCO; CuSO

Indexed as

Antibodies, MonoclonalImmunoglobulin GMetalsPolysorbatesCatalysisCircular DichroismHumansOxidation-ReductionProtein Conformation, beta-StrandProtein StabilityRituximabTrastuzumabAntibodies, MonoclonalImmunoglobulin GMetalsPolysorbatesRituximabTrastuzumabhigher-order structuremonoclonal antibodyoxidationpolysorbatestability

Identifiers

PMID40202920
PMCPMC12118537

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Registered trials

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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.