Evidence map›Paper›PMID 28454057›Full record

ArticleJournal of pharmaceutical and biomedical analysis2017

Application of 2D-NMR with room temperature NMR probes for the assessment of the higher order structure of filgrastim.

Robert G Brinson, Houman Ghasriani, Derek J Hodgson, Kristie M Adams, Ian McEwen, Darón I Freedberg, Kang Chen, David A Keire, Yves Aubin, John P Marino

Abstract read
In one paragraph

Article in Journal of pharmaceutical and biomedical analysis, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.0field-weighted citation impact, top 25% 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

11 citing papers in PubMed, 14 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Review
  7. Selective suppression of excipient signals in 2DJournal of biomolecular NMR · 2018
    Article
  8. Article
  9. Article
  10. Multivariate Analysis of Two-DimensionalAnalytical chemistry · 2017
    Article
  11. 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

10 authors at 7 institutions in 3 countries.

Robert G BrinsonInstitute for Bioscience and Biotechnology Research, National Institute of Standards and Technology and the University of Maryland, 9600 Gudelsky Drive, Rockville, MD 20850, United States.
Houman GhasrianiU.S. Food & Drug Administration, Center for Drug Evaluation and Research, Division of Pharmaceutical Analysis, 645 S. Newstead Avenue, St. Louis, MO 63110, United States; Centre for Biologics Evaluation, Biologics and Genetic Therapies Directorate, Health Canada, 251 Sir Frederick Banting Drive, Ottawa, ON K1A 0K9, Canada.
Derek J HodgsonCentre for Biologics Evaluation, Biologics and Genetic Therapies Directorate, Health Canada, 251 Sir Frederick Banting Drive, Ottawa, ON K1A 0K9, Canada.
Kristie M AdamsUnited States Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852, United States.
Ian McEwenMedical Products Agency of Sweden, P.O. Box 26 SE-75103, Uppsala, Sweden.
Darón I FreedbergLaboratory of Bacterial Polysaccharides, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20903, United States.
Kang ChenU.S. Food & Drug Administration, Center for Drug Evaluation and Research, Division of Pharmaceutical Analysis, 645 S. Newstead Avenue, St. Louis, MO 63110, United States.
David A KeireU.S. Food & Drug Administration, Center for Drug Evaluation and Research, Division of Pharmaceutical Analysis, 645 S. Newstead Avenue, St. Louis, MO 63110, United States. Electronic address: David.Keire@fda.hhs.gov.
Yves AubinCentre for Biologics Evaluation, Biologics and Genetic Therapies Directorate, Health Canada, 251 Sir Frederick Banting Drive, Ottawa, ON K1A 0K9, Canada. Electronic address: yves.aubin@hc-sc.gc.ca.
John P MarinoInstitute for Bioscience and Biotechnology Research, National Institute of Standards and Technology and the University of Maryland, 9600 Gudelsky Drive, Rockville, MD 20850, United States. Electronic address: john.marino@nist.gov.
Center for Drug Evaluation and Research · USHealth Canada · CANational Institute of Standards and Technology · USCenter for Biologics Evaluation and Research · USMedical Products Agency · SEUnited States Food and Drug Administration · USUnited States Pharmacopeial Convention · US

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

The higher order structure (HOS) of biotherapeutics is a critical quality attribute that can be evaluated by nuclear magnetic resonance (NMR) spectroscopy at atomic resolution. NMR spectral mapping of HOS can be used to establish HOS consistency of a biologic across manufacturing changes or to compare a biosimilar to an innovator reference product. A previous inter-laboratory study performed using filgrastim drug products demonstrated that two-dimensional (2D)-NMR

Indexed as

Magnetic Resonance SpectroscopyFilgrastimTemperatureFilgrastim2D-NMRBiologicsFingerprintingHigher order structurePCA

Identifiers

PMID28454057
PMCPMC6057790
OpenAlexW2605341073

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.