Evidence map›Paper›PMID 21491437›Full record

ArticleJournal of pharmaceutical sciences2011

The utility of hydrogen/deuterium exchange mass spectrometry in biopharmaceutical comparability studies.

Damian Houde, Steven A Berkowitz, John R Engen

Abstract readComparative Study
In one paragraph

Article in Journal of pharmaceutical sciences, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 183 papers.

0numbers the graph read from it
0cells of the map it votes in
183citing papers in PubMed
8.8field-weighted citation impact, top 1% 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

183 citing papers in PubMed, 378 citations in OpenAlex.

  1. Article
  2. Modulating pseudokinase conformation from the ATP-binding site.Structure (London, England : 1993) · 2026
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  20. Mapping HDX-MS Data to Protein Conformations through Training Ensemble-Based Models.Journal of the American Society for Mass Spectrometry · 2023
    Article

123 more citing papers are in PubMed but not listed here.

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

3 authors at 2 institutions in 1 country.

Damian HoudeBiogen Idec, Inc, Cambridge, Massachusetts 02142, USA.
Steven A Berkowitz
John R Engen
Biogen (United States) · USNortheastern University · US

Funding

Protein conformational change upon membrane associationR01GM086507 · NIGMS · NORTHEASTERN UNIVERSITY · PI ENGEN, JOHN R · 2009 to 2012
$1.6M
Structural Dynamics of Src-Family Kinase ActivationR01GM070590 · NIGMS · UNIVERSITY OF NEW MEXICO · PI ENGEN, JOHN R · 2004 to 2008
$1.5M
NIGMS NIH HHS R01 GM070590NIGMS NIH HHS R01-GM070590NIGMS NIH HHS R01 GM086507NIGMS NIH HHS R01-GM086507
6 · The paper itself

Abstract

The function, efficacy, and safety of protein biopharmaceuticals are tied to their three-dimensional structure. The analysis and verification of this higher-order structure are critical in demonstrating manufacturing consistency and in establishing the absence of structural changes in response to changes in production. It is, therefore, essential to have reliable, high-resolution and high sensitivity biophysical tools capable of interrogating protein structure and conformation. Here, we demonstrate the use of hydrogen/deuterium exchange mass spectrometry (H/DX-MS) in biopharmaceutical comparability studies. H/DX-MS measurements can be conducted with good precision, consume only picomoles of protein, interrogate nearly the entire molecule with peptide level resolution, and can be completed in a few days. Structural comparability or lack of comparability was monitored for different preparations of interferon-β-1a. We present specific graphical formats for the display of H/DX-MS data that aid in rapidly making both the qualitative (visual) and quantitative assessment of comparability. H/DX-MS is capable of making significant contributions in biopharmaceutical characterization by providing more informative and confidant comparability assessments of protein higher-order structures than are currently available within the biopharmaceutical industry.

Indexed as

Deuterium Exchange MeasurementMass SpectrometryBiopharmaceuticsInterferonsModels, MolecularProtein ConformationProteinsTechnology, PharmaceuticalInterferonsProteins

Identifiers

PMID21491437
PMCPMC3164548
OpenAlexW1996334859

What OpenQuestion holds

Textmetadata
LicenceTDM
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.