USP mAb 002，单抗IgG1

• 尺寸排阻色谱
• 毛细管 SDS 电泳（还原和非还原）
• 分析N-连接寡糖
• 唾液酸分析
• Intact Mass分析
• 通过肽图分析进行序列鉴定

• 4种具有独特质量性质的独特蛋白。
• 广泛表征带来对方法开发的信心
• 技术说明可提供

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.