Evidence map›Paper›PMID 34445776›Full record

ArticleInternational journal of molecular sciences2021

Simultaneous Monitoring of Monoclonal Antibody Variants by Strong Cation-Exchange Chromatography Hyphenated to Mass Spectrometry to Assess Quality Attributes of Rituximab-Based Biotherapeutics.

Fiammetta Di Marco, Thomas Berger, Wolfgang Esser-Skala, Erdmann Rapp, Christof Regl, Christian G Huber

Open access · goldAbstract read
In one paragraph

Article in International journal of molecular sciences, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.2field-weighted citation impact, top 21% of its field
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

8 citing papers in PubMed, 19 citations in OpenAlex.

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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

6 authors at 2 institutions in 2 countries.

Fiammetta Di MarcoDepartment of Biosciences, Bioanalytical Research Labs, University of Salzburg, Hellbrunner Straße 34, 5020 Salzburg, Austria.ORCID 0000-0002-8505-6622
Thomas BergerDepartment of Biosciences, Bioanalytical Research Labs, University of Salzburg, Hellbrunner Straße 34, 5020 Salzburg, Austria.
Wolfgang Esser-SkalaDepartment of Biosciences, Bioanalytical Research Labs, University of Salzburg, Hellbrunner Straße 34, 5020 Salzburg, Austria.ORCID 0000-0002-7350-4045
Erdmann RappglyXera GmbH, Brenneckestraße 20-ZENIT, 39120 Magdeburg, Germany.ORCID 0000-0001-6618-2626
Christof ReglDepartment of Biosciences, Bioanalytical Research Labs, University of Salzburg, Hellbrunner Straße 34, 5020 Salzburg, Austria.
Christian G HuberDepartment of Biosciences, Bioanalytical Research Labs, University of Salzburg, Hellbrunner Straße 34, 5020 Salzburg, Austria.ORCID 0000-0001-8358-1880
University of Salzburg · ATMax Planck Institute for Dynamics of Complex Technical Systems · DE

Funding

Austrian Science Fund W1213Christian Doppler Forschungsgesellschaft N.A.
6 · The paper itself

Abstract

Different manufacturing processes and storage conditions of biotherapeutics can lead to a significant variability in drug products arising from chemical and enzymatic post-translational modifications (PTMs), resulting in the co-existence of a plethora of proteoforms with different physicochemical properties. To unravel the heterogeneity of these proteoforms, novel approaches employing strong cation-exchange (SCX) high-performance liquid chromatography (HPLC) hyphenated to mass spectrometry (MS) using a pH gradient of volatile salts have been developed in recent years. Here, we apply an established SCX-HPLC-MS method to characterize and compare two rituximab-based biotherapeutics, the originator MabThera

Indexed as

Antibodies, MonoclonalAntineoplastic Agents, ImmunologicalBiosimilar PharmaceuticalsCationsChromatography, AffinityChromatography, High Pressure LiquidGlycosylationMass SpectrometryRituximabAntibodies, MonoclonalAntineoplastic Agents, ImmunologicalBiosimilar PharmaceuticalsCationsRituximabbiosimilarcharged variant separationMabThera®mass spectrometrymonoclonal antibodiespH gradientpost-translational modificationsReditux™strong cation-exchange chromatography

Identifiers

PMID34445776
PMCPMC8396523
OpenAlexW3195997704

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.