Continuous pharmaceutical process engineering and economics Investigating technical efficiency, environmental impact and economic viability

摘要

Continuous Pharmaceutical Manufacturing (CPM) emerges as a ground-breaking technology which can invigorate the global pharmaceutical industry by sustainably fostering its agility and the affordability of healthcare for large populations. Continuous production methods feature numerous significant technical advantages, which however need be ensured by robust, scaleable chemistry, systematic process design and efficient Process Analytical Technology (PAT) for control. Quality by Design (QbD) must be achieved by a relentless pursuit of efficiency in energy and solvent use, but above all the business case for a product must be strong enough to cover both synthesis and process R&D against competition. Remarkable corporate investments in production-scale CPM facilities illustrate the value and promise of this paradigm. This paper focuses on applications of process systems engineering methodologies (flowsheet modelling and simulation) toward evaluating the technical efficiency, environmental impact and economic viability of two continuous processes. Original final upstream separation results for ibuprofen and recent ones for plantwide CPM economics are discussed.