Skip To
Product Name
USP mAb 002, Monoclonal IgG1, United States Pharmacopeia (USP) Reference Standard
format
neat
form
liquid
mol wt
~150,000 Da
packaging
pkg of 2 mg
manufacturer/tradename
USP
application(s)
USP Biologics
pharmaceutical
storage temp.
−70°C
1 of 4
This Item | 1445539 | 1445595 | SAB4200683 |
|---|---|---|---|
| manufacturer/tradename USP | manufacturer/tradename USP | manufacturer/tradename USP | manufacturer/tradename - |
| format neat | format neat | format neat | format - |
| application(s) pharmaceutical | application(s) pharmaceutical | application(s) pharmaceutical | application(s) - |
| mol wt ~150,000 Da | mol wt ~147,000 Da | mol wt ~146,000 Da | mol wt - |
| packaging pkg of 2 mg | packaging pkg of 2 mg | packaging pkg of 2 mg | packaging - |
| storage temp. −70°C | storage temp. −70°C | storage temp. −70°C | storage temp. −20°C |
Analysis Note
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
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.
Other Notes
Storage Class
12 - Non Combustible Liquids
wgk
WGK 1
flash_point_f
Not applicable
flash_point_c
Not applicable
Choose from one of the most recent versions:
Already Own This Product?
Find documentation for the products that you have recently purchased in the Document Library.
Related Content
Order from a broad range of highly characterized primary reference standard materials to use with USP-NF monographs for the testing of drug substances & dosage forms, pharmaceutical excipients, food ingredients and dietary supplements.
Discover our wide variety of products for intact mass analysis of monoclonal antibodies, including size-exclusion columns (SEC), ion exchange columns, reverse-phase columns, HPLC buffers, MALDI matrices and standards, high-purity solvents, reagents, tools for protein sample preparation, and certified reference materials.
Active Filters
Our team of scientists has experience in all areas of research including Life Science, Material Science, Chemical Synthesis, Chromatography, Analytical and many others.
Contact Technical Service