曲妥珠单抗原液生产车间工艺设计

Process design of trastuzumab monoclonal antibody ManufacturingProduction WorkshopsAbstractTrastuzumab is a recombinant humanized monoclonal antibody directed against theextracellular region of the HER2 protein for the treatment of metastatic breast cancer (MBC)overexpressing HER2I11.Monotherapy can be used for metastatic breast cancer that hasreceived one or more chemotherapy regimens;it can be combined with paclitaxel to treatmetastatic breast cancer that has not received chemotherapy.This design is the Process design of trastuzumab monoclonal antibody ManufacturingProduction Workshops.The design contents mainly include seed cell recovery and cultureexpansion,antibody purification,equipment selection,and workshop layout design.Thedesign uses a bioreactor,a deep filtration system,and Protein A affinity chromatography toproduce trastuzumab antigen solution.In accordance with the process conditions,followingthe principles of high efficiency,low energy consumption and low cost,the layout of thetrastuzumabtrastuzumab monoclonal antibody Manufacturing Production Workshops incompliance with GMP requirements was designed.Key words:trastuzumab;breast cancer;bioreactor;antibody purification;workshop layout