Currently, there is a high level of interest in the pharmaceutical industry in continuous-manufacturing strategies, integrated with online-monitoring tools, that are designed, optimized, and controlled using advanced, model-predictive systems. These strategies can accelerate the full implementation of the quality-by-design (QbD) paradigm for the next generation of pharmaceutical products. In addition to its flexibility and time- and cost-saving features, continuous manufacturing is intrinsically steady and therefore easily amenable to model predictive design, optimization, and control methods. These methods have proven to be effective approaches to improve operational efficiency and have been widely used in various process industries. Excitingly, in the pharmaceutical industry, the application of the model-predictive design, optimization, and control is virgin territory, wide open to researchers and technology providers.

• U.S. Food and Drug Administration (US FDA)

• API

1. API
2. continuous processing
3. Control strategy
4. Process analytical technology
5. quality by design
6. Review article
7. Traceability