Flatman Stephen, Alam Imtiaz, Gerard Jeffery, Mussa Nesredin
Lonza Biologics Plc, 228 Bath Road, Slough, Berkshire SL1 4DX, UK.
J Chromatogr B Analyt Technol Biomed Life Sci. 2007 Mar 15;848(1):79-87. doi: 10.1016/j.jchromb.2006.11.018. Epub 2006 Dec 11.
The application of appropriate analytical methods is an essential requirement for the purification of therapeutic antibodies. A range of analytical methods need to be employed to effectively determine the purity, identity, integrity and activity of these important class of pharmaceuticals. These include notably electrophoresis, high performance liquid chromatography and immunoassays. Regulatory and industry demands in recent years have brought the need for improvements and many have been successfully implemented. This article reviews the current analytical methods applied to support the purification of monoclonal antibodies.
应用适当的分析方法是治疗性抗体纯化的一项基本要求。需要采用一系列分析方法来有效测定这类重要药物的纯度、特性、完整性和活性。其中特别包括电泳、高效液相色谱法和免疫测定法。近年来，监管要求和行业需求推动了改进的必要性，并且许多改进已经成功实施。本文综述了目前用于支持单克隆抗体纯化的分析方法。
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