1445595

USP mAb 003, Monoclonal IgG1

United States Pharmacopeia (USP) Reference Standard

• Synonym(s): Monoclonal IgG1
• CAS Number: 912628-39-8
• MDL number: MFCD01570845
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• form: liquid
• mol wt: ~146,000 Da
• packaging: pkg of 2 mg
• manufacturer/tradename: USP
• application(s): pharmaceutical
• format: neat
• storage temp.: −70°C

Description

General description

USP mAb 003 Monoclonal IgG1 is a standardized monoclonal antibody of the IgG1 subclass. It serves as a critical reference standard for analytical procedures, facilitating the calibration and validation of assays employed in the characterization and quantification of therapeutic mAbs.

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 physicochemical 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

This product is part of the USP Biologics program.

USP has developed four monoclonal antibody Reference Standards (mAb System Suitability, mAb 001, mAb 002, and mAb 003) to provide a range of reference materials with different physicochemical properties. These products underwent USP′s rigorous collaborative testing process including assessment by the USP General Chapter 129 methods.

Sales restrictions may apply.

Safety Information

• Storage Class: 12 - Non Combustible Liquids
• wgk_germany: WGK 2
• flash_point_f: Not applicable
• flash_point_c: Not applicable