Modular and reconfigurable factories for continuous production innovation in pharmaceutical manufacturing
本文针对生物制药生产系统开发慢、修改难的问题，提出将传统系统拆分为无菌生产创新工厂和合规无菌生产工厂，两者均采用高度模块化、可变更的架构，并通过数字设计与仿真加速新产品引入、员工培训和验证。
Biologically-based drugs can target a broader range of diseases with increased precision than traditional synthesised drugs, enabling the targeting of rare diseases. This shift impacts production systems, as batch sizes decrease and portfolio diversity increases. While initiatives exist to revolutionise production systems using state-of-the-art technologies, they often overlook the full life cycle of production systems holistically, including design, reconfiguration, and scaling. This paper outlines the pharmaceutical industry's need for purpose-built production systems that are fast to develop and modify. It proposes splitting traditional production systems into an aseptic production innovation factory and derived Good-Manufacturing-Practise-compliant aseptic production factories, both relying on a highly modular, changeable architecture. The proposed conceptual architecture is exemplified on various use cases, highlighting how it accelerates new products and technology introduction, supports employee training, and accelerates validation compared to conventional approaches. This is achieved by transitioning from digital design and simulation through the aseptic production innovation factory into validated aseptic production factories. While the architecture addresses key challenges of current pharmaceutical production systems, it is not without risk. Companies must take ownership of this architecture, especially its digital viewpoint, and rely on collaborations and co-development with technology providers to achieve modularity and reconfigurability across all structural levels.