Evidence map›Paper›PMID 36442848›Full record

ArticleJournal of the American Society for Mass Spectrometry2022

Comprehensive Multidimensional Liquid Chromatography-Mass Spectrometry for the Characterization of Charge Variants of a Bispecific Antibody.

Ingrid Grunert, Katrin Heinrich, Michael Hingar, Juliane Ernst, Martin Winter, Katrin Bomans, Katharina Wagner, Arnaud Fevre, Dietmar Reusch, Manfred Wuhrer and 1 more

Abstract read
In one paragraph

Article in Journal of the American Society for Mass Spectrometry, 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
–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

11 authors.

Ingrid GrunertPharma Technical Development, Roche Diagnostics GmbH, 82377 Penzberg, Germany.ORCID 0000-0002-5596-1015
Katrin HeinrichPharma Technical Development, Roche Diagnostics GmbH, 82377 Penzberg, Germany.
Michael HingarPharma Technical Development, Roche Diagnostics GmbH, 82377 Penzberg, Germany.
Juliane ErnstPharma Technical Development, Roche Diagnostics GmbH, 82377 Penzberg, Germany.
Martin WinterPharma Technical Development, Roche Diagnostics GmbH, 82377 Penzberg, Germany.
Katrin BomansPharma Technical Development, Roche Diagnostics GmbH, 82377 Penzberg, Germany.
Katharina WagnerPharma Technical Development, Roche Diagnostics GmbH, 82377 Penzberg, Germany.
Arnaud FevrePharma Technical Development, Hoffmann-La Roche, 4070 Basel, Switzerland.ORCID 0000-0001-6536-9384
Dietmar ReuschPharma Technical Development, Roche Diagnostics GmbH, 82377 Penzberg, Germany.
Manfred WuhrerCenter for Proteomics and Metabolomics, Leiden University Medical Center, 2333 Leiden, The Netherlands.ORCID 0000-0002-0814-4995
Patrick BulauPharma Technical Development, Hoffmann-La Roche, 4070 Basel, Switzerland.ORCID 0000-0002-7121-2954

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Identification and further characterization of antibody charge variants is a crucial step during biopharmaceutical drug development, particularly with regard to the increasing complexity of novel antibody formats. As a standard analytical approach, manual offline fractionation of charge variants by cation-exchange chromatography followed by comprehensive analytical testing is applied. These conventional workflows are time-consuming and labor-intensive and overall reach their limits in terms of chromatographic separation of enhanced structural heterogeneities raised from new antibody formats. For these reasons, we aimed to develop an alternative online characterization strategy for charge variant characterization of a therapeutic bispecific antibody by online mD-LC-MS at middle-up (2D-LC-MS) and bottom-up (4D-LC-MS) level. Using the implemented online mD-LC-MS approach, all medium- and even low-abundant product variants previously identified by offline fraction experiments and liquid chromatography mass spectrometry could be monitored. The herein reported automated online mD-LC-MS methodology therefore represents a complementary and in part alternative approach for analytical method validation including multiattribute monitoring (MAM) strategies by mass spectrometry, offering various benefits including increased throughput and reduced sample handling and combined protein information at intact protein and peptide level.

Indexed as

Research DesignChromatography, LiquidMass Spectrometryautomationbispecific antibodiescation-exchange chromatographycritical quality attributesmass spectrometrymultiattribute monitoringmultidimensional liquid chromatographyonline HPLCproduct variants

Identifiers

PMID36442848
PMCPMC9732868

What OpenQuestion holds

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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.