Issue link: https://www.e-digitaleditions.com/i/1499609
20 Pharmaceutical Technology ® Trends in Manufacturing eBook May 2023 PharmTech.com IM IMAGERY - STOCK.ADOBE.COM T he future continuous pharmaceutical man- ufacturing is desired to be based on modu- lar plug-and-play concept. In this approach, mobile modules consisting of a group of unit operations need to be developed that can be easily reconfigured to assemble a scalable phar- maceutical manufacturing process for different products. It is also suitable for on-demand urgent manufacturing such as in the case of the COVID-19 pandemic. However, because of different levels of complexity, the development and adaptation of flexible and modular CM plants is still an open area of research (1-3). Therefore, a systematic framework of methods and tools are needed to develop, adapt, and evaluate the flexible modular CM plant for API manufacturing with reduced time and resources. In particular, a digital twin is critical for quick design, adaptation, optimization, scale up, and control of continuous APIs manufacturing process, allowing for virtual modeling of operations without extensive process development. In this work, a digital twin for continuous APIs m a nu f ac t u r i n g pr oces s u si n g modu l a r compo - nents has been developed. This involves building a digital twin model librar y of the unit operations com mon ly used i n cont i nuous A PI ma nu fac t u r- ing processes t hat can be easi ly integrated to de- velop the integrated digital system for a range of drug manufacturing processes. Such a toolbox will great ly faci litate t he implementation of econom- ica l ly competitive API manufact uring processes, significantly enabling reshoring of API manufac- turing activities, and will support effective "digital evaluation" of the manufacturing process by regula- tors. Additionally, the toolbox will greatly facilitate digital process design, digital process implementa- tion, digital scale-up, and process optimization for API manufacturing systems. Advanced Continuous Manufacturing of Drugs Ravendra Singh is faculty of the Department of Chemical and Biochemical Engineering at Rutgers University. Advanced continuous manufacturing with modular components is emerging as a preferred platform to produce APIs.