Evidence map›Paper›PMID 30570405›Full record

ArticlemAbs2019

Enabling adoption of 2D-NMR for the higher order structure assessment of monoclonal antibody therapeutics.

Robert G Brinson, John P Marino, Frank Delaglio, Luke W Arbogast, Ryan M Evans, Anthony Kearsley, Geneviève Gingras, Houman Ghasriani, Yves Aubin, Gregory K Pierens and 39 more

Abstract read
In one paragraph

Article in mAbs, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 60 papers.

0numbers the graph read from it
0cells of the map it votes in
60citing 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

60 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Next-generation inhibitors of SARS-CoV-2 MNature communications · 2026
    Article
  6. Article
  7. Heptad insertion extends theBiodesign research · 2026
    Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Review
  18. Article
  19. Article
  20. Expression ofEPJ web of conferences · 2023
    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

49 authors.

Robert G Brinsona Institute of Bioscience and Biotechnology Research , National Institute of Standards and Technology and the University of Maryland , Rockville , MD , USA.
John P Marinoa Institute of Bioscience and Biotechnology Research , National Institute of Standards and Technology and the University of Maryland , Rockville , MD , USA.
Frank Delaglioa Institute of Bioscience and Biotechnology Research , National Institute of Standards and Technology and the University of Maryland , Rockville , MD , USA.
Luke W Arbogasta Institute of Bioscience and Biotechnology Research , National Institute of Standards and Technology and the University of Maryland , Rockville , MD , USA.ORCID 0000-0001-6871-450X
Ryan M Evansb Applied and Computational Mathematics Division , National Institute of Standards and Technology , Gaithersburg , MD , USA.
Anthony Kearsleyb Applied and Computational Mathematics Division , National Institute of Standards and Technology , Gaithersburg , MD , USA.
Geneviève Gingrasc Centre for Biologics Evaluation, Biologics and Genetic Therapies Directorate , Health Canada , Ottawa , ON , Canada.
Houman Ghasrianic Centre for Biologics Evaluation, Biologics and Genetic Therapies Directorate , Health Canada , Ottawa , ON , Canada.ORCID 0000-0002-9646-0006
Yves Aubinc Centre for Biologics Evaluation, Biologics and Genetic Therapies Directorate , Health Canada , Ottawa , ON , Canada.ORCID 0000-0002-8554-0297
Gregory K Pierensd The Centre for Advanced Imaging , The University of Queensland , St Lucia , QLD , Australia.
Xinying Jiad The Centre for Advanced Imaging , The University of Queensland , St Lucia , QLD , Australia.ORCID 0000-0002-2831-4605
Mehdi Moblid The Centre for Advanced Imaging , The University of Queensland , St Lucia , QLD , Australia.ORCID 0000-0003-2420-4262
Hamish G Grante Bio21 Molecular Science & Biotechnology Institute , The University of Melbourne , Victoria , Australia.
David W Keizere Bio21 Molecular Science & Biotechnology Institute , The University of Melbourne , Victoria , Australia.
Kristian Schweimerf Lehrstuhl Biopolymere , Universitaet Bayreuth , Bayreuth , Germany.
Jonas Ståhleg Department of Organic Chemistry , Arrhenius Laboratory, Stockholm University , Stockholm , Sweden.ORCID 0000-0001-5657-8635
Göran Widmalmg Department of Organic Chemistry , Arrhenius Laboratory, Stockholm University , Stockholm , Sweden.
Edward R Zartlerh Analytical R&D , Pfizer Essential Health , Lake Forest , IL , USA.
Chad W Lawrencei Pacific Northwest National Laboratory , Earth and Biological Sciences Directorate , Richland , DC , USA.
Patrick N Reardoni Pacific Northwest National Laboratory , Earth and Biological Sciences Directorate , Richland , DC , USA.ORCID 0000-0002-6858-0086
John R Corti Pacific Northwest National Laboratory , Earth and Biological Sciences Directorate , Richland , DC , USA.ORCID 0000-0001-6342-6461
Ping Xuj Department of Downstream Processing and Analytics , Human Health Therapeutics Research Centre, National Research Council of Canada , Montreal , Quebec , Canada.
Feng Nij Department of Downstream Processing and Analytics , Human Health Therapeutics Research Centre, National Research Council of Canada , Montreal , Quebec , Canada.
Saeko Yanakak Institute for Molecular Science and Exploratory Research Center on Life and Living Systems , National Institutes of Natural Sciences , Myodaiji, Okazaki , Japan.
Koichi Katok Institute for Molecular Science and Exploratory Research Center on Life and Living Systems , National Institutes of Natural Sciences , Myodaiji, Okazaki , Japan.
Stuart R Parnhaml Department of Biochemistry and Molecular Biology , Medical University of South Carolina , Charleston , SC , USA.ORCID 0000-0002-8205-5827
Desiree Tsaom Analytical Development , Momenta Pharmaceuticals , Cambridge , MA , USA.
Andreas Blomgrenn Laboratory Unit , Swedish Medical Products Agency, Laboratory , Uppsala , Sweden.ORCID 0000-0001-8171-4678
Torgny Rundlöfn Laboratory Unit , Swedish Medical Products Agency, Laboratory , Uppsala , Sweden.ORCID 0000-0001-9004-7272
Nils Trieloffo NMR-supported Structural Biology , Leibniz-Forschungsinstitut für Molekulare Pharmakologie (FMP) , Berlin , Germany.ORCID 0000-0002-3530-9273
Peter Schmiedero NMR-supported Structural Biology , Leibniz-Forschungsinstitut für Molekulare Pharmakologie (FMP) , Berlin , Germany.
Alfred Rossp Roche Pharmaceutical Research & Early Development , Pre-Clinical CMC, Roche Innovation Center Basel , Basel , Switzerland.
Ken Skidmoreq Analytical Operations , Genentech , South San Francisco , CA , USA.
Kang Chenr Center for Drug Evaluation and Research , Food and Drug Administration , Maryland , USA.ORCID 0000-0003-0276-2474
David Keirer Center for Drug Evaluation and Research , Food and Drug Administration , Maryland , USA.ORCID 0000-0002-7767-7904
Darón I Freedbergs Center for Biologics Evaluation and Research , Food and Drug Administration , Maryland , USA.ORCID 0000-0003-1991-5174
Thea Suter-Stahelt Department of Biology , Institute of Molecular Biology and Biophysics , ETH Zurich, Zurich , Switzerland.
Gerhard Widert Department of Biology , Institute of Molecular Biology and Biophysics , ETH Zurich, Zurich , Switzerland.
Gregor Ilcu NMR Centre , EN-FIST Centre of Excellence , Ljubljana , Slovenia.
Janez Plavecu NMR Centre , EN-FIST Centre of Excellence , Ljubljana , Slovenia.ORCID 0000-0003-1570-8602
Scott A Bradleyw Eli Lilly and Company , Lilly Corporate Center , Indianapolis , IN , USA.
Donna M Baldisserix MRS - Application Science , Bruker BioSpin Corporation , Billerica , MA , USA.
Mauricio Luis Sforçay Brazilian Biosciences National Laboratory (LNBio), Brazilian Center for Research in Energy and Materials (CNPEM) , Campinas, Brazil.
Ana Carolina de Mattos Zeriz Brazilian Synchrotron Light Laboratory (LNLS), Brazilian Center for Research in Energy and Materials (CNPEM) , Campinas, Brazil , CEP.
Julie Yu Weiaa Protein Product Development , Biogen Inc ., Cambridge , MA , USA.
Christina M Szaboab Baxter Pharmaceuticals R&D , Baxter Healthcare , Round Lake, IL , USA.ORCID 0000-0003-0403-6337
Carlos A Amezcuaab Baxter Pharmaceuticals R&D , Baxter Healthcare , Round Lake, IL , USA.ORCID 0000-0003-1644-8689
John B Jordanac Global Regulatory and R&D Policy , Amgen Inc ., Thousand Oaks , CA , USA.
Mats Wikströmad Higher Order Structure, Attribute Sciences , Amgen Inc ., Thousand Oaks , CA , USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The increased interest in using monoclonal antibodies (mAbs) as a platform for biopharmaceuticals has led to the need for new analytical techniques that can precisely assess physicochemical properties of these large and very complex drugs for the purpose of correctly identifying quality attributes (QA). One QA, higher order structure (HOS), is unique to biopharmaceuticals and essential for establishing consistency in biopharmaceutical manufacturing, detecting process-related variations from manufacturing changes and establishing comparability between biologic products. To address this measurement challenge, two-dimensional nuclear magnetic resonance spectroscopy (2D-NMR) methods were introduced that allow for the precise atomic-level comparison of the HOS between two proteins, including mAbs. Here, an inter-laboratory comparison involving 26 industrial, government and academic laboratories worldwide was performed as a benchmark using the NISTmAb, from the National Institute of Standards and Technology (NIST), to facilitate the translation of the 2D-NMR method into routine use for biopharmaceutical product development. Two-dimensional

Indexed as

Antibodies, MonoclonalBiopharmaceuticsHumansLaboratoriesMagnetic Resonance SpectroscopyReproducibility of ResultsAntibodies, Monoclonalchemometricscomparabilityhigher order structuremonoclonal antibody (mAb) therapeuticsNISTmAbnuclear magnetic resonance spectroscopy (NMR)

Identifiers

PMID30570405
PMCPMC6343768

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.