单抗药物发展趋势及工程设计分析

Development Trend and Engineering Design Analysis of Monoclonal Antibody Drugs

单抗产业正进入关键的发展时期,未来随着医保对于单抗药物的覆盖加大以及国内单抗产业的发展,市场将继续维持高速增长。本文简要介绍了单抗药物生产过程中上游工艺、下游工艺和制剂工艺的工艺流程,并对上游工艺和下游工艺的主要工艺区域进行详细介绍,最后结合人物流设计、空调系统及公用工程系统设计对单抗生产车间的设计做简要分析。

Monoclonal antibody industry is entering a critical development period.In the future,with the increasing coverage of medical insurance for monoclonal antibody drugs and the development of domestic monoclonal antibody industry,the market will continue to maintain rapid growth.This paper briefly introduces the process flow of upstream process,downstream process and preparation process in the production of monoclonal antibody,and introduces the main process areas of upstream process and downstream process in detail.Finally,the design of monoclonal antibody production workshop is briefly analyzed in combination with the design of human logistics,air conditioning system and utility system.