治疗性单克隆抗体在医院配制后及给患者使用前的质量控制。
Quality Control of Therapeutic Monoclonal Antibodies at the Hospital After Their Compounding and Before Their Administration to Patients.
作者信息
Jaccoulet Emmanuel, Smadja Claire, Taverna Myriam
机构信息
Institut Galien Paris-Sud, UMR 8612, Proteins and Nanotechnology in Analytical Science, CNRS, Univ Paris-Sud, Univ Paris-Saclay, 5 rue Jean-Baptiste Clément, 92296, Châtenay-Malabry, France.
Hôpital Européen Georges Pompidou, Paris, France.
出版信息
Methods Mol Biol. 2016;1466:179-84. doi: 10.1007/978-1-4939-4014-1_14.
Monoclonal antibodies (mAbs) are widely used in cancer therapy and recently many new mAbs have gained EMA and FDA approvals for oncology indications. Here we describe a highly reproducible CZE method, relying on a cationic coating allowing separation and identification of a complex mixture of four compounded mAbs widely used in cancer therapy (cetuximab, rituximab, bevacizumab, and trastuzumab).
单克隆抗体（mAb）广泛应用于癌症治疗，最近许多新型单克隆抗体已获得欧洲药品管理局（EMA）和美国食品药品监督管理局（FDA）的肿瘤学适应症批准。在此，我们描述了一种高度可重复的毛细管区带电泳（CZE）方法，该方法基于阳离子涂层，可分离和鉴定癌症治疗中广泛使用的四种复合单克隆抗体（西妥昔单抗、利妥昔单抗、贝伐单抗和曲妥珠单抗）的复杂混合物。
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