【摘要】 为了对单克隆抗体（m Abs）下游生产亲和层析步骤做全面的成本评价，利用Excel建立一个包含单柱层析和3柱连续流层析所有步骤的成本模型。分析所有的成本项，包括设备、填料、缓冲液等。用每克商品成本（COG）来定量描述不同场景的成本比较。结果表明，每批纯化500和2 000 L的收获细胞培养液（HCCF），滴度为5 g·L^-1，年产37批，收率为95%，成本占比靠前的总是填料、设备和缓冲液。当年纯化批数改变，其他条件不变，每批纯化500 L的HCCF，批次数达到20以上，3柱连续层析才能突显出优势，而每批纯化2 000 L的HCCF时只需要大于7个批次就能显示出优势。当HCCF滴度从低到高变化时，2类工艺成本的降低都是先快后慢，滴度达到8 g·L^-1后，成本变化变得相对稳定。另外，一次性层析系统的使用，也会导致成本增长。以上结果为蛋白A层析的优化指出方向，为抗体产品的生产提供合理的工艺选择。更多还原

【Abstract】 In order to make a comprehensive cost evaluation of affinity chromatography downstream processing of monoclonal antibody （m Abs）,an Excel cost model was built including all steps of single column chromatography and three-column periodic counter-current chromatography （3C-PCC）.Cost items including equipment,resins,buffers are then analyzed.Finally,the total costs were normalized as the costs per gram of purified protein and the costs of goods per gram （COG） can be compared in a variety of process scenarios.The results show that when operated under purification of 500 L and 2 000 L harvested cell culture fluid（HCCF）,titer 5 g·L^-1,annual output 37 batches,yield 95%,three items at the top of costs were always resin,equipment and buffer.When the purification batch numbers changed and other conditions kept constant for 500 L HCCF,the batch numbers need to reach over 20 for the 3C-PCC system to show advantage.While only over 7 batches were needed for the 2 000 L HCCF to show the advantage of the 3C-PCC system.When the titer changed from low to high,the reduction in cost decrease fast and then slowed for both processes.After the titer reac hed 8g·L^-1,the cost was relatively stable.In addition,the single-use chromatography equipment can also result in cost increase.The above results are useful for process optimization of protein A chromatography and provide guidance for process selection of antibody production.更多还原