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Characterizing monoclonal antibody formulations in arginine glutamate solutions using ¹H NMR spectroscopy.

ABSTRACT: Assessing how excipients affect the self-association of monoclonal antibodies (mAbs) requires informative and direct in situ measurements for highly concentrated solutions, without sample dilution or perturbation. This study explores the application of solution nuclear magnetic resonance (NMR) spectroscopy for characterization of typical mAb behavior in formulations containing arginine glutamate. The data show that the analysis of signal intensities in 1D ¹H NMR spectra, when compensated for changes in buffer viscosity, is invaluable for identifying conditions where protein-protein interactions are minimized. NMR-derived molecular translational diffusion rates for concentrated solutions are less useful than transverse relaxation rates as parameters defining optimal formulation. Furthermore, NMR reports on the solution viscosity and mAb aggregation during accelerated stability study assessment, generating data consistent with that acquired by size-exclusion chromatography. The methodology developed here offers NMR spectroscopy as a new tool providing complementary information useful to formulation development of mAbs and other large therapeutic proteins.

SUBMITTER: Kheddo P

PROVIDER: S-EPMC5058632 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature

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Characterizing monoclonal antibody formulations in arginine glutamate solutions using <sup>1</sup>H NMR spectroscopy.

Kheddo Priscilla P Cliff Matthew J MJ Uddin Shahid S van der Walle Christopher F CF Golovanov Alexander P AP

mAbs 20160811 7

Assessing how excipients affect the self-association of monoclonal antibodies (mAbs) requires informative and direct in situ measurements for highly concentrated solutions, without sample dilution or perturbation. This study explores the application of solution nuclear magnetic resonance (NMR) spectroscopy for characterization of typical mAb behavior in formulations containing arginine glutamate. The data show that the analysis of signal intensities in 1D <sup>1</sup>H NMR spectra, when compensa ...[more]

PMID: 27589351

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Dataset Information

Characterizing monoclonal antibody formulations in arginine glutamate solutions using 1H NMR spectroscopy.

Publications

Characterizing monoclonal antibody formulations in arginine glutamate solutions using <sup>1</sup>H NMR spectroscopy.

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Characterizing monoclonal antibody formulations in arginine glutamate solutions using ¹H NMR spectroscopy.