Advanced Continuous Manufacturing of Drugs

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The future continuous pharmaceutical manufacturing is desired to be based on modular 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 pharmaceutical 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 manufacturing process using modular components has been developed. This involves building a digital twin model library of the unit operations commonly used in continuous API manufacturing processes that can be easily integrated to develop the integrated digital system for a range of drug manufacturing processes. Such a toolbox will greatly facilitate the implementation of economically competitive API manufacturing processes, significantly enabling reshoring of API manufacturing activities, and will support effective “digital evaluation” of the manufacturing process by regulators. Additionally, the toolbox will greatly facilitate digital process design, digital process implementation, digital scale-up, and process optimization for API manufacturing systems.

Read this article in the Pharmaceutical Technology Trends in Manufacturing 2023 eBook

About the author

Ravendra Singh is faculty of the Department of Chemical and Biochemical Engineering at Rutgers University.

Article details

Pharmaceutical Technology
eBook: Trends in Manufacturing

May 2023
Pages: 20-24

Citation

When referring to this article, please cite it as R. Singh, "Advanced Continuous Manufacturing of Drugs," Pharmaceutical Technology's Trends in Manufacturing eBook (May 2023).