Build consistency and reproducibility into your analytical methods.

The USP Monoclonal IgG System Suitability RS was developed to establish clearly defined requirements for system suitability for the test methods in USP General Chapter <129> Analytical Procedures for Recombinant Therapeutic Monoclonal Antibodies. Chapter <129> provides validated analytical procedures for monoclonal antibody purity assessments by size exclusion chromatography and capillary sodium dodecyl sulfate (CE–SDS) electrophoresis, as well as oligosaccharide and sialic acid analysis.

Three new monoclonal antibody Reference Standards (all IgG1 subclass) are now available. These new products underwent USP’s rigorous collaborative testing process that included not only assessment by the USP General Chapter <129> methods but also assessment of N-glycans, sialic acid, intact mass, sequence identification by peptide mapping, and additional post-translational modifications. Although all are of the same subclass, they are unique proteins with unique quality attributes. Upon release, important differences between the monoclonal antibodies will be provided in a technical note so that you can pick ones containing attributes that are best for your particular needs. These reference standards can be used for many non-compendial purposes that a laboratory may need including:

• as an independent control material for method development, training, and method transfer
• as an internal assay control
• for standardization of physico-chemical testing, such as intact mass, charge heterogeneity, size variants, purity, and glycan analyses.

Now Available