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Beschreibung

The NIST monoclonal antibody (NISTmAb) reference material (RM) is a recombinant humanized IgG1? expressed in murine suspension culture and has undergone biopharmaceutical industry standard upstream and downstream purification to remove process related impurities. It is an ~150 kDa homodimer of two light chain and two heavy chain subunits linked through both inter- and intra-chain disulfide bonds. The molecule has a high abundance of N-terminal pyroglutamination, C-terminal lysine clipping, and glycosylation of the heavy chains. The protein also has low abundance post-translational modifications including methionine oxidation, deamidation, and glycation. These and other product quality attributes were extensively characterized in the ACS Symposium Series for the initial batch of interim material, used as the primary standard (PS) herein.-