单克隆抗体药物生产车间（抛弃型设备）工程设计探讨

摘要

Currently there are two equipment for producing monoclonal antibody-traditional equipment and one time usage disposable one. Combined with the requirements in china GMP (2010 Revised Edition) and with one practical example, the layout design of workshop equipped with one time usage equipment was analyzed and discussed in this article.%现阶段，国内企业（含外企）单克隆抗体（以下简称“单抗”）药物生产设备主要有传统型生产设备和一次性抛弃型生产设备两种。通过项目设计实例，结合中国 GMP（2010修订版）的要求，就一次性抛弃型生产设备的车间布局设计进行探讨与分析。