曲妥珠单抗原液生产车间工艺设计

北京理工大学珠海学院 2020 届本科生毕业设计曲妥珠单抗原液生产车间工艺设计曲妥珠单抗原液生产车间工艺设计摘 要曲妥珠单抗是针对 HER2 蛋白细胞外区域的重组人源化单克隆抗体，用于治疗过表达 HER2 的转移性乳腺癌（MBC）[1]。单药治疗可用于已接受过一个或多个化疗方案的转移性乳腺癌；可与紫杉醇联合治疗未接受过化疗的转移性乳腺癌。本设计为曲妥珠单抗原液生产车间工艺设计，设计内容主要包括种子细胞复苏及培养扩增、抗体纯化、设备选型、车间布置图设计等。本设计以生物反应器、深层过滤系统、Protein A 亲和层析等方法对曲妥珠单抗原液进行生产。在满足工艺条件下，遵循高效率，低能耗，低成本的原则，设计符合 GMP 要求的曲妥珠单抗原液生产车间布置方案。关键词：曲妥珠单抗；乳腺癌；生物反应器；抗体纯化；车间布置北京理工大学珠海学院 2020 届本科生毕业设计 北京理工大学珠海学院 2020 届本科生毕业设计Process design of trastuzumab monoclonal antibody Manufacturing Production WorkshopsAbstractTrastuzumab is a recombinant humanized monoclonal antibody directed against the extracellular region of the HER2 protein for the treatment of metastatic breast cancer (MBC) overexpressing HER2[1]. Monotherapy can be used for metastatic breast cancer that has received one or more chemotherapy regimens; it can be combined with paclitaxel to treat metastatic breast cancer that has not received chemotherapy.This design is the Process design of trastuzumab monoclonal antibody Manufacturing Production Workshops. The design contents mainly include seed cell recovery and culture expansion, antibody purification, equipment selection, and workshop layout design. The design uses a bioreactor, a deep filtration system, and Protein A affinity chromatography to produce trastuzumab antigen solution. In accordance with the process conditions, following the principles of high efficiency, low energy consumption and low cost, the layout of the trastuzumab trastuzumab monoclonal antibody M...