I北京理工大学珠海学院 2020 届本科生毕业设计利妥昔单抗原液生产车间工艺设计II北京理工大学珠海学院 2020 届本科生毕业设计摘要利妥昔单抗是目前世界上治疗淋巴瘤最重要的药物之一，且近年来研究发现其在治疗肾脏疾病中也有重要应用。当前我国生产利妥昔单抗的企业有限，而需求量又比较多，因此设计一间生产利妥昔单抗原液的生产车间具有非常大的市场前景。本设计的工艺流程主要分为细胞大规模培养、层析纯化这两个阶段，其中选用了流加式分批补料的方式在 2000L 发酵罐中进行大规模生产利妥昔单抗，并在下游工艺中采用亲和层析和两步离子交换层析对利妥昔单抗进行纯化精制，目的是达到产率高、纯度高的利妥昔单抗原液。根据发酵罐使用时间设计每年生产 15 个批次。本设计内容主要包括利妥昔单抗的相关介绍，工艺流程的选择和设计，每个周期及全年的关键物料衡算和主要的热量衡算、水平衡计算和耗冷量计算，以及生产工艺流程图、设备的选型及设备一览表、车间平面布置图。关键词：利妥昔单抗；发酵；层析；生产车间；设计III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 lymphoma around the world, and in recent years, it has also been found to have important applications in the treatment of kidney diseases. Currently, China's rituximab production enterprises are limited, and the demand is relatively large, so the design of a production workshop of rituximab liquid has a very big market prospect.The design process is mainly divided into cells of mass culture, these two stages of chromatography purification, which chooses the flow and type of batch feeding way for mass production in the 2000L fermentation tank rituxan, and used in the downstream process affinity chromatography and two-step ion exchange chromatography for purification of rituxan refined, purpose is to achieve high yield, high purity of rituxan concentrate. It is designed to produce 15 batches per year according to the use time of fermentation tank.This d...
