Monoclonal Antibody System Suitability Standard

Ensuring quality in monoclonal antibody development with USP standards

COVID-19 is transforming our ways of thinking about the development, manufacture, and delivery of critical medicines to patients around the world. Monoclonal Antibodies have shown to be promising candidates as viable weapons to treat COVID19.

As the development and manufacture of mAb treatments expedite the production of mAb treatments to address existing as well as emerging public health needs, USP’s public quality standards are available to manufacturers and regulators as critical tools for ensuring the quality and safety of monoclonal antibodies. USP compendial tests and methods can be used efficiently and confidently by manufacturers as a benchmark for assessing quality parameters like glycosylation, charge variants, contamination control and stability testing.

Learn more about USP quality standards for mAb therapeutics in the attached infographics.


Build consistency and reproducibility into your analytical methods

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.