利妥昔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AbstractRituximab is one of the most important medicine in the treatment of lymphomaaround the world,and in recent years,it has also been found to have importantapplications in the treatment of kidney diseases.Currently,China's rituximabproduction enterprises are limited,and the demand is relatively large,so the design ofa production workshop of rituximab liquid has a very big market prospect.The design process is mainly divided into cells of mass culture,these two stagesof chromatography purification,which chooses the flow and type of batch feedingway for mass production in the 2000L fermentation tank rituxan,and used in thedownstream process affinity chromatography and two-step ion exchangechromatography for purification of rituxan refined,purpose is to achieve high yield,high purity of rituxan concentrate.It is designed to produce 15 batches per yearaccording to the use time of fermentation tank.This design mainly includes the related introduction of rituximab,the selectionand design of process flow,the key material balance and the main heat balance,waterbalance and cooling calculation for each cycle and the whole year,as well as theproduction process flow chart,equipment selection and equipment list,workshoplayout.Key words Rituximab:fermentation chromatography The productionworkshop:design