基于PCS7的BATCH控制在生物制药单抗生产中的应用

Application of BATCH Control Based on PCS7 in the Production of Biopharmaceutical Monoclonal Antibody

随着生物制药的发展,单抗药物的生产越来越朝着系统化、集成化、数字化的方向发展。针对单抗药物复杂的工艺生产过程和配方多变的生产方式。本文采用西门子PCS7全集成DCS系统,利用符合ISA-S88标准的批量控制软件和配方管理,研究单抗控制方案和第三方设备集成方案,设计出适用于单抗生产的批次控制DCS系统,满足其生产工艺、参数多变的柔性化需求和数据完整性要求。

With the development of biopharmaceuticals,the production of monoclonal antibodies is more and more systematic,integrated and digital.In view of the complex technological production process of monoclonal antibody drugs and the production mode with variable formulations.In this paper,Using the Siemens PCS7 fully integrated DCS system,batch control software and formula management conforming to ISA-S88 standard are used to study the control scheme of monoclonal antibody and the integration scheme of third-party equipment,and a batch control DCS system suitable for the production of monoclonal antibody is designed to meet the flexible requirements and data integrity requirements of its production process and parameters.