人源化mAb质量检查标准 | 186009125

The analysis of intact proteins by LC-MS is a preferred approach for the characterization of biopharmaceuticals, in particular monoclonal antibodies (mAbs).  In such an analysis, it is possible to acquire intact mass information, quickly confirm sequence and post-translation modifications, as well as interrogate product related impurities.  To support this application area, Waters has commercialized the Humanized mAb Mass Check Standard, which can be used in the benchmarking of LC-MS techniques, proficiency testing among different instruments and laboratories, and system suitability when doing intact protein analysis.  This standard is a stabilized and lyophilized format of NIST Reference Material 8671 (NIST mAb), a humanized IgG1κ expressed from a murine cell line.*  Each vial of the standard is provided in an approximately 80 µg quantity.