Evidence map›Paper›PMID 28106519›Full record

ArticlemAbs2017

Subunit mass analysis for monitoring antibody oxidation.

Izabela Sokolowska, Jingjie Mo, Jia Dong, Michael J Lewis, Ping Hu

Abstract read
In one paragraph

Article in mAbs, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing 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

19 citing papers in PubMed.

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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.

Izabela Sokolowskaa Large Molecules Analytical Development , Pharmaceutical Development & Manufacturing Sciences, Janssen Research & Development, LLC , Malvern , PA , USA.
Jingjie Moa Large Molecules Analytical Development , Pharmaceutical Development & Manufacturing Sciences, Janssen Research & Development, LLC , Malvern , PA , USA.
Jia Donga Large Molecules Analytical Development , Pharmaceutical Development & Manufacturing Sciences, Janssen Research & Development, LLC , Malvern , PA , USA.
Michael J Lewisa Large Molecules Analytical Development , Pharmaceutical Development & Manufacturing Sciences, Janssen Research & Development, LLC , Malvern , PA , USA.
Ping Hua Large Molecules Analytical Development , Pharmaceutical Development & Manufacturing Sciences, Janssen Research & Development, LLC , Malvern , PA , USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Methionine oxidation is a common posttranslational modification (PTM) of monoclonal antibodies (mAbs). Oxidation can reduce the in-vivo half-life, efficacy and stability of the product. Peptide mapping is commonly used to monitor the levels of oxidation, but this is a relatively time-consuming method. A high-throughput, automated subunit mass analysis method was developed to monitor antibody methionine oxidation. In this method, samples were treated with IdeS, EndoS and dithiothreitol to generate three individual IgG subunits (light chain, Fd' and single chain Fc). These subunits were analyzed by reversed phase-ultra performance liquid chromatography coupled with an online quadrupole time-of-flight mass spectrometer and the levels of oxidation on each subunit were quantitated based on the deconvoluted mass spectra using the UNIFI software. The oxidation results obtained by subunit mass analysis correlated well with the results obtained by peptide mapping. Method qualification demonstrated that this subunit method had excellent repeatability and intermediate precision. In addition, UNIFI software used in this application allows automated data acquisition and processing, which makes this method suitable for high-throughput process monitoring and product characterization. Finally, subunit mass analysis revealed the different patterns of Fc methionine oxidation induced by chemical and photo stress, which makes it attractive for investigating the root cause of oxidation.

Indexed as

AnimalsAntibodies, MonoclonalChromatography, High Pressure LiquidHigh-Throughput Screening AssaysHumansMass SpectrometryMethionineOxidation-ReductionAntibodies, MonoclonalMethionineFcLC-MSmass spectrometrymethionine oxidationmonoclonal antibodyposttranslational modificationsprocess monitoringproduct characterizationsubunit mass analysis

Identifiers

PMID28106519
PMCPMC5384710

What OpenQuestion holds

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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.