Monoclonal Antibody System Suitability Standard

Build consistency and reproducibility into your analytical methods for monoclonal antibodies with USP standards

USP’s public quality standards are critical tools for manufacturers and regulators to help ensure the quality of monoclonal antibodies. USP compendial tests and Reference Standards can be used efficiently and confidently to characterize and measure quality parameters like glycosylation, charge variants, sterility, and during stability testing.

USP has developed four monoclonal antibody Reference Standards (mAb System Suitability, mAb 001, mAb 002, and mAb 003) to overcome the limited availability of consistent, highly characterized mAb standards and to provide a range of reference materials with different physico-chemical properties.  These 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 IgG1 subclass, they are unique proteins with unique quality attributes.  Important details and differences between the monoclonal antibodies are provided in a technical note so that you can pick ones containing attributes that are best for your particular needs.  Over time, USP scientists and collaborators will continue to release new uses* for these materials. These reference standards can be used for many 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.


 

Reference Standards

Monoclonal Antibodies - Now Available – New Applications for USP mAb Reference Standards: Resolving Charge Variants*

Monoclonal IgG Suitability (Cat # 1445550)
Monoclonal IgG1, mAb 001 RS (Cat # 1445539)*
Monoclonal IgG1, mAb 002 RS (Cat # 1445547)*
Monoclonal IgG1, mAb 003 RS (Cat # 1445595)*

Related Reference Standards

Glycan Profiling

N-Acetylneuraminic Acid (Cat # 1612619)
N-Glycolylneuraminic Acid (Cat # 1294284)
Oligosaccharide System Suitability Mixture A (Cat # 1478210)
Oligosaccharide System Suitability Mixture B (Cat # 1478221)   
Oligosaccharide System Suitability Mixture C (Cat # 1478232)
Oligosaccharide System Suitability Mixture D (Cat # 1478243)

Impurities

CHO Genomic DNA (Cat # 1130710)
E. coli Genomic DNA (Cat # 1231557)

Adventitious Agents

Endotoxins (Cat # 1235503)

Download the Complimentary Chapter <129>

Supporting USP Education Courses (full list available at https://www.usp.org/biologics/education):

  • USP’s Work Supporting Multi-Attribute Methods for Biologics (On-Demand)
  • What’s New in Biologics? Focus on USP’s Monoclonal Antibody Reference Standards (Live Webcast)
  • Analysis of Charge Variants in Biologics (Live Webcast)