Evidence map›Paper›PMID 35895102›Full record

ArticleAnalytical and bioanalytical chemistry2022

Comparison of originator and biosimilar monoclonal antibodies using HRMS, Fc affinity chromatography, and 2D-HPLC.

Lars M H Reinders, Martin D Klassen, Thorsten Teutenberg, Martin Jaeger, Torsten C Schmidt

Abstract read
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In one paragraph

Article in Analytical and bioanalytical chemistry, 2022. 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
0.3field-weighted citation impact, top 45% 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

1 citing paper in PubMed, 4 citations in OpenAlex.

  1. Review
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 at 3 institutions in 1 country.

Lars M H ReindersInstitut Für Energie- und Umwelttechnik e. V. (IUTA, Institute of Energy and Environmental Technology), Bliersheimer Str. 58-60, 47229, Duisburg, Germany.
Martin D KlassenInstitut Für Energie- und Umwelttechnik e. V. (IUTA, Institute of Energy and Environmental Technology), Bliersheimer Str. 58-60, 47229, Duisburg, Germany.
Thorsten TeutenbergInstitut Für Energie- und Umwelttechnik e. V. (IUTA, Institute of Energy and Environmental Technology), Bliersheimer Str. 58-60, 47229, Duisburg, Germany. teutenberg@iuta.de.ORCID http://orcid.org/0000-0002-2477-6167
Martin JaegerHochschule Niederrhein (University of Applied Science), Reinarzstr. 49, 47805, Krefeld, Germany.
Torsten C SchmidtInstrumental Analytical Chemistry, Faculty of Chemistry, University Duisburg-Essen, Universitätsstr. 5, 45141, Essen, Germany.
Hochschule Niederrhein · DEInstitut für Energie- und Umwelttechnik · DEUniversity of Duisburg-Essen · DE

Funding

Bundesministerium für Wirtschaft und Energie 49VF170039
6 · The paper itself

Abstract

Due to the complex manufacturing process of therapeutic monoclonal antibodies, it is hardly possible to produce an identical copy of the original product (originator). Consequently, follow-on products (biosimilars) must demonstrate their efficacy being similar to the originator in terms of structure and function. During this process, a variety of analytical methods are required for this purpose. This study focuses on three particularly relevant analytical techniques: high-resolution mass spectrometry, fragment crystallisable (Fc) affinity chromatography, and two-dimensional peptide mapping. Each analytical method proved able to identify specific differences between originator and biosimilar. High-resolution mass spectrometry was used to characterize the glycan pattern. It was shown that a trastuzumab biosimilar did not have the G0:G0F sugar modification identified in the originator. The application of affinity chromatography to rituximab showed that originator and biosimilar interacted differently with the immobilized Fc receptor. Furthermore, 2D-HPLC peptide mapping demonstrated the influence of orthogonality of separation dimensions, leading to differentiation of a rituximab originator and biosimilar.

Indexed as

Antineoplastic Agents, ImmunologicalBiosimilar PharmaceuticalsAntibodies, MonoclonalChromatography, AffinityChromatography, High Pressure LiquidRituximabAntibodies, MonoclonalAntineoplastic Agents, ImmunologicalBiosimilar PharmaceuticalsRituximab2D-HPLCBiosimilarFcR affinity chromatographyHigh-resolution mass spectrometry (HRMS)Monoclonal antibody (mAb)

Identifiers

PMID35895102
OpenAlexW4288176173

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.