Enabling adoption of 2D-NMR for the higher order structure assessment of monoclonal antibody therapeutics.

ABSTRACT: The increased interest in using monoclonal antibodies (mAbs) as a platform for biopharmaceuticals has led to the need for new analytical techniques that can precisely assess physicochemical properties of these large and very complex drugs for the purpose of correctly identifying quality attributes (QA). One QA, higher order structure (HOS), is unique to biopharmaceuticals and essential for establishing consistency in biopharmaceutical manufacturing, detecting process-related variations from manufacturing changes and establishing comparability between biologic products. To address this measurement challenge, two-dimensional nuclear magnetic resonance spectroscopy (2D-NMR) methods were introduced that allow for the precise atomic-level comparison of the HOS between two proteins, including mA

SUBMITTER: Brinson RG 

PROVIDER: S-EPMC6343768 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature