Design, optimization, monitoring and control of continuous pharmaceutical manufacturing plant for QbD and PAT based next generation of efficient manufacturing

摘要

A novel manufacturing strategy based on continuous processing integrated with inline/online monitoring tools (PAT) coupled with efficient automatic advanced feedback control system is highly desired for efficient QbD based manufacturing of the next generation of pharmaceutical products with optimal consumption of time, space and resources. However, the particulate systems are still poorly understood and there is different level of complexities involved, therefore to achieve this paradigm shift, new techniques and tools need to be developed through extensive fundamental and applied research. This area of research and education are highly encouraged and supported by pharmaceutical companies, academic institutions, regulatory authority (FDA) and national science foundation (NSF). For example, recently national science foundation of USA has established a 100 million dollar research center for structured organic particulate systems (C-SOPS) at Rutgers University New Jersey. Furthermore, more than 40 companies are supporting this center economically and providing scientific inputs so that the research outcomes can be directly applied to the companies.