Guo Jingzhong, Tu Huiping, Jing Li, McCarthy Diane, Atouf Fouad
Global Biologics, Science Division, United States Pharmacopeia, Rockville, MD 20852, USA.
Pharmaceuticals (Basel). 2022 Mar 5;15(3):315. doi: 10.3390/ph15030315.
The glycan profile is a critical quality attribute for pharmaceutical monoclonal antibodies due to the potential physiological impact of the glycan composition when used as a drug product. Monoclonal antibody reference standards are useful as system suitability samples for glycan profile testing. The development of future glycan profiling techniques could be better evaluated by testing well-characterized reference standards. The USP has introduced monoclonal antibody reference standards (i.e., USP mAb 001 RS, USP mAb 002 RS, and USP mAb 003 RS) with the glycan profiles reported herein that can be used to assess the analytical testing of monoclonal antibody glycan profiles. Comparison of the USP reference standards to other available reference standards (NISTmAb) is presented. The glycan profile of the USP monoclonal antibody reference standards covers a range of glycan species that complements other available reference standards. The USP mAb reference standards are a valuable tool that can be used to verify the glycan structure and provide the system suitability of analytical methods.
由于聚糖组成在用作药品时具有潜在的生理影响，聚糖谱是药用单克隆抗体的关键质量属性。单克隆抗体参考标准品作为聚糖谱测试的系统适用性样品很有用。通过测试特征明确的参考标准品，可以更好地评估未来聚糖谱分析技术的发展。美国药典（USP）已推出单克隆抗体参考标准品（即USP mAb 001 RS、USP mAb 002 RS和USP mAb 003 RS），本文报告了其聚糖谱，可用于评估单克隆抗体聚糖谱的分析测试。还展示了USP参考标准品与其他可用参考标准品（NISTmAb）的比较。USP单克隆抗体参考标准品的聚糖谱涵盖了一系列聚糖种类，对其他可用参考标准品起到补充作用。USP mAb参考标准品是一种有价值的工具，可用于验证聚糖结构并提供分析方法的系统适用性。
