Background References

Selected Biopharmaceutical 2D-NMR Publications

  • Hodgson DJ, Ghasriani H, Aubin Y. Assessment of the higher order structure of Humira®, Remicade®, Avastin®, Rituxan®, Herceptin®, and Enbrel® by 2D-NMR fingerprinting. Journal of Pharmaceutical and Biomedical Analysis 2019, 163, 144 - 152.
  • Arbogast LW, Delaglio F, Schiel JE, Marino JP. Multivariate analysis of two-dimensional 1H, 13C methyl NMR spectra of monoclonal antibody therapeutics to facilitate assessment of higher order structure. Analytical Chemistry 2017, 89,11839 - 11845.
  • Japelj B, Ilc G, Marusic J, Sencar J, Kuzman D, Plavec J. Biosimilar structural comparability assessment by NMR: from small proteins to monoclonal antibodies. Scientific Reports 2016, 6, 32201.
  • Ghasriani H, Hodgson DJ, Brinson RG, McEwen I, Buhse LF, Kozlowski S, Marino, JP. Aubin, Y., Keire, D. Precision and robustness of 2D-NMR for structure assessment of filgrastim biosimilars. Nature Biotechnology 2016, 34, 139 - 141.
  • Arbogast LW, Brinson RG, Marino JP. Mapping monoclonal antibody structure by 2D 13C NMR at natural abundance. Analytical Chemistry 2015, 87, 3556 - 3561.
  • Aubin Y, Gingras G, Sauve S. Assessment of the three-dimensional structure of recombinant protein therapeutics by NMR fingerprinting: demonstration on recombinant human granulocyte macrophage-colony stimulation factor. Analytical Chemistry 2008, 80, 2623 - 2627.

 

Selected NISTmAb Publications

  • Schiel JE, Davis DL, Borisov OV, eds. State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization, Vol 1: Monoclonal Antibody Therapeutics: Structure, Function, and Regulatory Space . Washington, D.C.: American Chemical Society, 2014, 1176.
  • Schiel JE, Davis DL, Borisov OV, eds. State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization, Vol 2: Biopharmaceutical Characterization: The NISTmAb Case Study. Washington, D.C.: American Chemical Society, 2015, 1201.
  • Schiel JE, Davis DL, Borisov OV, eds. State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization, Vol 3: Defining the Next Generation of Analytical and Biophysical Techniques. Washington, D.C.: American Chemical Society, 2015, 1202.
  • Schiel JE, Turner A. The NISTmAb Reference Material 8671 lifecycle management and quality plan. Analytical and Bioanalytical Chemistry 2018, 410, 2067 - 2078.
  • Schiel JE, Turner A, Mouchahoir T, Yandrofski K, Telikepalli S, King J, et al. The NISTmAb Reference Material 8671 value assignment, homogeneity, and stability. Analytical and Bioanalytical Chemistry 2018, 410, 2127 - 2039 .

 

***This reference list is not intended to be comprehensive. Rather it represents a few important publications relevant to the interlaboratory NMR study.***