Biophysical characterization and structure of the Fab fragment from the NIST reference antibody, RM 8671.

ABSTRACT: Monoclonal antibody pharmaceuticals are the fastest-growing class of therapeutics, with a wide range of clinical applications. To assure their safety, these protein drugs must demonstrate highly consistent purity and stability. Key to these objectives is higher order structure measurements validated by calibration to reference materials. We describe preparation, characterization, and crystal structure of the Fab fragment prepared from the NIST Reference Antibody RM 8671 (NISTmAb). NISTmAb is a humanized IgG1κ antibody, produced in murine cell culture and purified by standard biopharmaceutical production methods, developed at the National Institute of Standards and Technology (NIST) to serve as a reference material. The Fab fragment was derived from NISTmAb through papain cleavage followed

SUBMITTER: Karageorgos I 

PROVIDER: S-EPMC5856035 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature