USP mAb 001, Monoclonal IgG1

USP mAb 001 is a recombinant human monoclonal IgG1 antibody used as a representative analytical standard. It supports identity testing, aggregation analysis, glycosylation profiling, and system suitability in methods developed for monoclonal antibody characterization and biosimilar comparison.

The USP biologics monoclonal antibodies (mAb) category includes a range of therapeutic proteins that are designed to target specific antigens, providing effective treatments for various diseases, including cancers and autoimmune disorders. Monoclonal antibodies are produced using hybridoma technology and are essential in both diagnostics and therapeutics. The USP provides comprehensive standards, reference materials, and analytical procedures to ensure the identity, quality, purity, and consistency of monoclonal antibody products throughout their lifecycle.

The United States Pharmacopeia (USP) provides quality standards for biologics to ensure their safety, efficacy, and quality throughout the manufacturing process. These standards assist manufacturers in adhering to regulatory requirements and help safeguard public health by reducing risks associated with biologics.

• Size-Exclusion Chromatography
• Capillary SDS Electrophoresis (Reduced and Nonreduced)
• Analysis of N-Linked Oligosaccharides
• Sialic Acid Analysis
• Intact Mass
• Sequence identification by peptide mapping
• Independent control material for method development, training, and method transfer
• Internal assay control for standardization of physico-chemical testing

• 4 Unique proteins with unique quality attributes
• Extensively characterized for confidence in method development
• Technical Note available