USP Monoclonal IgG system suitability RS
Molecular weight ~150 kDa
2mg of IgG lyophilized monoclonal antibody
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.
USP mAb 001 RS
Molecular weight ~148 kDa
200 µL of 10 mg/mL IgG1 monoclonal antibody in 25 mM Citrate, 0.90%(w/v) Sodium Chloride, 0.07% Polysorbate 80, pH 6.5
USP mAb 002 RS
Molecular weight ~150 kDa
200 µL of 10 mg/mL IgG1 monoclonal antibody in 0.58% Monobasic sodium phosphate monohydrate, 0.12% Dibasic sodium phosphate anhydrous, 6% α, α-trehalose dihydrate , 0.04% Polysorbate 20, pH 6.2
USP mAb 003 RS
Molecular weight ~146 kDa
200 µL of 10 mg/mL IgG1 monoclonal antibody in 20 mM Histidine HCl, 120 mM Sucrose, 0.02% Polysorbate 20, pH 6.0
Call for participation in a laboratory study on the analysis of monoclonal antibodies
USP will be releasing three new monoclonal antibody standards soon and is planning a round robin study to expand upon the collaborative testing of these materials to include additional laboratories and analytical methods. The study will include tests from USP Chapter〈129〉Analytical Procedures for Recombinant Therapeutic Monoclonal Antibodies (e.g. SEC-HPLC, CE-SDS, oligosaccharides) as well as non-compendial tests (e.g. cIEF/icIEF, MS-based glycan, MW by MS). The opportunity to evaluate the new standards using in-house assays will also be available. If your laboratory is interested in participating in all or part of this study, please contact USP at USPBiologics@USP.org. Deadline is October 1, 2020.
- USP Publishes Monoclonal Antibody Guidelines (Pharmtech)
- New USP Standards for Characterization of Therapeutic Proteins
- Journal of Pharmaceutical biomedical analysis; Implementation of USP antibody standard for system suitability in capillary electrophoresis sodium dodecyl sulfate (CE-SDS) for release and stability methods
- The Role of Public Standards in the Development of Biosimilars
- USP Reference Standards for Residual DNA Testing of Recombinant Biotherapeutics