1445547

USP mAb 002, Monoclonal IgG1

United States Pharmacopeia (USP) Reference Standard

• Synonym(s): Monoclonal IgG1
• CAS Number: 216974-75-3
• MDL number: MFCD00051787
• NACRES: NA.24
• UNSPSC Code: 41116107

Properties

• grade: pharmaceutical primary standard
• agency: USP
• form: liquid
• mol wt: ~150,000 Da
• packaging: pkg of 2 mg
• manufacturer/tradename: USP
• application(s): USP Biologics; pharmaceutical
• format: neat
• storage temp.: −70°C

Description

General description

USP mAb 002 is a second recombinant IgG1 monoclonal antibody standard provided by USP. It is used to evaluate analytical method robustness, control critical quality attributes (CQAs), and compare biosimilar candidates against originator monoclonal antibodies.

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.

Application

• 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

Features and Benefits

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

Analysis Note

These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.  

Other Notes

Sales restrictions may apply.

These products underwent USP′s rigorous collaborative testing process that including assessment by the USP General Chapter 129 methods.

This product is part of the USP Biologics program.

Safety Information

• Storage Class: 12 - Non Combustible Liquids
• wgk: WGK 1
• flash_point_f: Not applicable
• flash_point_c: Not applicable