This RM is primarily intended for use in evaluating the performance of methods for determining physiochemical and biophysical attributes of monoclonal antibodies. It also provides a representative test molecule for the development of novel technology in therapeutic protein characterization.
Other potential uses include system suitability tests, establishing method or instrument performance and variability, comparing changing analytical test methods, and assisting in method qualification.
NISTmAb, Humanized IgG1k Monoclonal Antibody has been used as a standard for testing de novo sequencing algorithm on bottom-up mass spectrometry.
NISTmAb, Humanized IgG1k Monoclonal Antibody is a recombinant antibody expressed in murine suspension culture. It is a homodimer with two identical light chains and two identical heavy chains linked through inter- and intra- chain disulfide bonds with a molecular weight of 150 kDa. The protein possesses low abundance post-translational modifications including methionine oxidation, deamidation, and glycation. The molecule also has N-terminal pyroglutamination, C-terminal lysine clipping, and glycosylation of the heavy chains.
NIST8671 is intended for research use. It is not intended for animal or human consumption, clinical testing or therapeutic use.
NIST is a registered trademark of National Institute of Standards and Technology