Build consistency and reproducibility into your analytical methods. A common analytical challenge associated with monoclonal antibody products is ascertaining if a specific method can resolve relevant product variants.

The USP monoclonal IgG system suitability standard was developed to address this issue by using a variety of analytical methods confirmed in an international round robin study, and extensive characterization of a monoclonal antibody material at six collaborative labs. 

USP monoclonal antibody reference standards (mAb RS) are recombinant humanized IgG1 that were expressed in Chinese hamster ovary (CHO) cell culture and have undergone industry standard upstream and downstream purification. USP mAb RS come in 3 molecular weights, each containing two identical light chains and two identical heavy chains linked through inter- and intra-chain disulfide bonds. The post-translational modifications include deamidation, methionine oxidation, tryptophan oxidation, N-terminal pyroglutamate, C-terminal lysine deletion, and N-glycosylation. 

These reference standards can be used as an independent control material for method development, training, method transfer, and internal assay control support, standardization of physico-chemical testing, such as intact mass, charge heterogeneity, size variants, purity, and glycan analyses.

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