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

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 ¹H^N-¹⁵N^H heteronuclear correlation spectroscopy is a highly robust and precise method for mapping the HOS of biologic drugs at natural abundance using high sensitivity NMR 'cold probes.' Here, the applicability of the 2D-NMR method to fingerprint the HOS of filgrastim products is demons

SUBMITTER: Brinson RG 

PROVIDER: S-EPMC6057790 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature