This is a preview of subscription content, access via your institution
Relevant articles
Open Access articles citing this article.
-
Comparability of Biologics: Global Principles, Evidentiary Consistency and Unrealized Reliance
BioDrugs Open Access 18 June 2021
-
Biosimilar structural comparability assessment by NMR: from small proteins to monoclonal antibodies
Scientific Reports Open Access 31 August 2016
Access options
Subscribe to this journal
Receive 12 print issues and online access
$209.00 per year
only $17.42 per issue
Rent or buy this article
Get just this article for as long as you need it
$39.95
Prices may be subject to local taxes which are calculated during checkout

References
Health Canada. Guidance for sponsors: information and submission requirements for subsequent entry biologics (SEBs) (publication 2010/03/05) (Health Canada Publications, 2010).
EMEA. Comparability of biotechnological/biological products subject to changes in their manufacturing process (CPMP/ICH/5721/03) (European Medicines Agency, 2006).
US Food and Drug Administration. Guidance for industry: quality considerations in demonstrating biosimilarity to a reference protein product (UCM291134) (US FDA Office of Communications, 2012).
US FDA. Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product (UCM291128) (US FDA Office of Communications, 2012).
Gabrielson, J.P. & Weiss, W.F. 4th. J. Pharm. Sci. 104, 1240–1245 (2015).
Aubin, Y., Gingras, G. & Sauvé, S. Anal. Chem. 80, 2623–2627 (2008).
Aubin, Y., Hodgson, D.J., Thach, W.B., Gingras, G. & Sauvé, S. Pharm. Res. 32, 3365–3375 (2015).
Baxter, N.J. & Williamson, M.P. Temperature dependence of 1H chemical shifts in proteins. J. Biomol. NMR 9, 359–369 (1997).
Williamson, M.P. Prog. Nucl. Magn. Reson. Spectrosc. 73, 1–16 (2013).
Arbogast, L.W., Brinson, R.G. & Marino, J.P. Anal. Chem. 87, 3556–3561 (2015).
Author information
Authors and Affiliations
Corresponding authors
Ethics declarations
Competing interests
The authors declare no competing financial interests.
Supplementary information
Supplementary Text and Figures
Supplementary Figures 1–4, Supplementary Tables 1–12 and Supplementary Methods (PDF 2210 kb)
Source data
Rights and permissions
About this article
Cite this article
Ghasriani, H., Hodgson, D., Brinson, R. et al. Precision and robustness of 2D-NMR for structure assessment of filgrastim biosimilars. Nat Biotechnol 34, 139–141 (2016). https://doi.org/10.1038/nbt.3474
Published:
Issue Date:
DOI: https://doi.org/10.1038/nbt.3474
This article is cited by
-
Structural Fingerprinting of Antisense Oligonucleotide Therapeutics by Solution NMR Spectroscopy
Pharmaceutical Research (2022)
-
Comparability of Biologics: Global Principles, Evidentiary Consistency and Unrealized Reliance
BioDrugs (2021)
-
Principal component analysis for automated classification of 2D spectra and interferograms of protein therapeutics: influence of noise, reconstruction details, and data preparation
Journal of Biomolecular NMR (2020)
-
Differentiating the Effects of Oxidative Stress Tests on Biopharmaceuticals
Pharmaceutical Research (2019)
-
Selective suppression of excipient signals in 2D 1H–13C methyl spectra of biopharmaceutical products
Journal of Biomolecular NMR (2018)