1445547

USP mAb 002, Monoclonal IgG1

United States Pharmacopeia (USP) Reference Standard

• 동의어(들): Monoclonal IgG1
• CAS Number: 216974-75-3
• MDL number: MFCD00051787
• UNSPSC 코드: 41116107
• NACRES: NA.24

속성

• 양식: liquid
• 분자량: ~150,000 Da
• 포장: pkg of 2 mg
• 제조업체/상표: USP
• 응용 분야: pharmaceutical
• 형식: neat
• 저장 온도: −70°C

설명

일반 설명

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.

애플리케이션

• 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

특징 및 장점

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

분석 메모

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.  

기타 정보

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.

Sales restrictions may apply.

안전성 정보

• Storage Class Code: 12 - Non Combustible Liquids
• WGK: WGK 1
• Flash Point (°F): Not applicable
• Flash Point (°C): Not applicable