摘要
目的:分析单克隆抗体一次性生产平台的成本与降低成本策略。方法:根据现有200 L单克隆抗体一次性生产平台的工艺流程,输入运行数据,耗材和人员成本,在SuperPro Designer工艺流程软件中建立流程模型并通过模拟运行计算生产成本。分别对成本中各项进行分析并调整优化。结果:平台工艺中耗材约占总成本60%,一次性储液袋占除去反复使用层析介质费用后耗材成本项的36%,按工艺流程看下游运行成本比上游更高,体现在较高的耗材和人工成本上。增加生产批次数量和改进亲和层析工艺至3次循环可以有效的降低生产成本,分别为26%和12%。结论:通过对单克隆抗体平台工艺的建模,细化分析各成本,并且与传统不锈钢体系的运营进行对比分析。基于分析结果,通过对工艺和批次优化调整,在200 L一次性生产规模上可使生产成本COG降至10 532元·g^(-1)单克隆抗体。
Objective： To analyze the process cost of MAb single-use manufacturing platform and explore the strategy to reduce the cost. Methods： Based on the real data from a 200 L single-use production line,a cost model was developed in Super Pro Designer software by modelling and inputting process parameters,consumable cost and labour cost et al. The cost in each category was then analyzed and the process cost was optimized by different cost saving strategies. Results： The cost of consumables contributed about 60% of the total manufacturing cost.Thirty-six percent of the consumable cost excluding reused chromatographic resins was from single-use buffer storage bags. The downstream cost was much higher than upstream in consumables and labour cost. Increasing annual batch number and the cycle number in the affinity chromatography process could effectively reduce the cost by 26%and 12% respectively. Conclusion： This paper analyzed the process economics and cost in detail by modelling the MAbsingle-use platform and compared with stainless steel platform. Based on the analysis results,the process and batch number were optimized,and the cost of goods（ COG） was reduced to 10 532 yuan·g-1monoclonal antibody for a 200 L scale single-use manufacturing platform.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2016年第1期56-63,共8页
Chinese Journal of New Drugs
