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Precision and robustness of 2D-NMR for structure assessment of filgrastim biosimilars

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Figure 1: Spectral and statistical comparisons of NMR data.


  1. Health Canada. Guidance for sponsors: information and submission requirements for subsequent entry biologics (SEBs) (publication 2010/03/05) (Health Canada Publications, 2010).

  2. EMEA. Comparability of biotechnological/biological products subject to changes in their manufacturing process (CPMP/ICH/5721/03) (European Medicines Agency, 2006).

  3. 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).

  4. US FDA. Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product (UCM291128) (US FDA Office of Communications, 2012).

  5. Gabrielson, J.P. & Weiss, W.F. 4th. J. Pharm. Sci. 104, 1240–1245 (2015).

    Article  CAS  Google Scholar 

  6. Aubin, Y., Gingras, G. & Sauvé, S. Anal. Chem. 80, 2623–2627 (2008).

    Article  CAS  Google Scholar 

  7. Aubin, Y., Hodgson, D.J., Thach, W.B., Gingras, G. & Sauvé, S. Pharm. Res. 32, 3365–3375 (2015).

    Article  CAS  Google Scholar 

  8. Baxter, N.J. & Williamson, M.P. Temperature dependence of 1H chemical shifts in proteins. J. Biomol. NMR 9, 359–369 (1997).

    Article  CAS  Google Scholar 

  9. Williamson, M.P. Prog. Nucl. Magn. Reson. Spectrosc. 73, 1–16 (2013).

    Article  CAS  Google Scholar 

  10. Arbogast, L.W., Brinson, R.G. & Marino, J.P. Anal. Chem. 87, 3556–3561 (2015).

    Article  CAS  Google Scholar 

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Correspondence to John P Marino, Yves Aubin or David A Keire.

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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).

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