Evidence map›Paper›PMID 37057828›Full record

ReviewmAbs

Mass spectrometry-based multi-attribute method in protein therapeutics product quality monitoring and quality control.

Feng Yang, Jennifer Zhang, Alexander Buettner, Eva Vosika, Monica Sadek, Zhiqi Hao, Dietmar Reusch, Maximiliane Koenig, Wayman Chan, Anja Bathke and 10 more

Open access · goldAbstract readReview
In one paragraph

Review in mAbs. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
7.1field-weighted citation impact, top 2% 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

22 citing papers in PubMed, 46 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

20 authors at 3 institutions in 3 countries.

Feng YangPharma Technical Development, Genentech, A member of the Roche Group, South San Francisco, CA, USA.
Jennifer ZhangPharma Technical Development, Genentech, A member of the Roche Group, South San Francisco, CA, USA.
Alexander BuettnerPharma Technical Development Analytics, Roche Diagnostics GmbH, Penzberg, Germany.
Eva VosikaPharma Technical Development Analytics, Roche Diagnostics GmbH, Penzberg, Germany.
Monica SadekPharma Technical Development, Genentech, A member of the Roche Group, South San Francisco, CA, USA.
Zhiqi HaoPharma Technical Development, Genentech, A member of the Roche Group, South San Francisco, CA, USA.
Dietmar ReuschPharma Technical Development Analytics, Roche Diagnostics GmbH, Penzberg, Germany.
Maximiliane KoenigLarge Molecule Research, Roche Pharma Research and Early Development, Roche Innovation Center Munich, Penzberg, Germany.
Wayman ChanPharma Technical Development, Genentech, A member of the Roche Group, South San Francisco, CA, USA.
Anja BathkePharma Technical Development, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
Hilary PallatPharma Quality & Compliance-Analytical Science, Genentech, A member of the Roche Group, South San Francisco, CA, USA.
Victor LundinPharma Technical Development, Genentech, A member of the Roche Group, South San Francisco, CA, USA.
Jochen Felix KepertPharma Technical Development Analytics, Roche Diagnostics GmbH, Penzberg, Germany.
Patrick BulauPharma Technical Development, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
Galahad DeperaltaPharma Technical Development, Genentech, A member of the Roche Group, South San Francisco, CA, USA.
Christopher YuPharma Technical Development, Genentech, A member of the Roche Group, South San Francisco, CA, USA.
Richard BeardsleyPharma Technical Development, Genentech, A member of the Roche Group, South San Francisco, CA, USA.
Tura CamilliPharma Technical Regulatory, Genentech, A Member of the Roche Group, South San Francisco, CA, USA.
Reed HarrisPharma Technical Development, Genentech, A member of the Roche Group, South San Francisco, CA, USA.
John StultsPharma Technical Development, Genentech, A member of the Roche Group, South San Francisco, CA, USA.
Roche (United States) · USRoche Pharma AG (Germany) · DERoche (Switzerland) · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The multi-attribute method (MAM), a liquid chromatography-mass spectrometry (LC-MS)-based peptide mapping method, has gained increased interest and applications in the biopharmaceutical industry. MAM can, in one method, provide targeted quantitation of multiple site-specific product quality attributes, as well as new peak detection. In this review, we focus on the scientific and regulatory considerations of using MAM in product quality attribute monitoring and quality control (QC) of therapeutic proteins. We highlight MAM implementation challenges and solutions with several case studies, and provide our perspective on the opportunities to use MS in QC for applications other than standard peptide mapping-based MAM.

Indexed as

Antibodies, MonoclonalBiological ProductsChromatography, LiquidMass SpectrometryQuality ControlAntibodies, MonoclonalBiological ProductscGMPGMPIntact MAMLC-MSMS in QCmulti-attribute methodnew peak detectionproduct quality attributequality controltargeted attribute quantitation

Identifiers

PMID37057828
PMCPMC10114992
OpenAlexW4365483718

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.