Process modelling, simulation and technoeconomic evaluation of batch vs. continuous pharmaceutical manufacturing (CPM) of cephalexin

Cost-effective antibiotics production is essential in the fight against antimicrobial resistance, since pharmaceutical companies must frequently abandon their antibiotics research due to: (i) high research and development (R&D) costs, (ii) increasingly stringent environmental regulations, and (iii) government initiatives aimed at curbing antimicrobial resistance by restricting use of new antibiotic products. Consequently, in-silico process design can be effectively employed to reduce the manufacturing cost of new and existing antibiotics whilst simultaneously accelerating their development and improving their affordability. The present paper examines how process modelling and technoeconomic evaluation can be used to guide the design of fully aqueous and aqueous two-phase system (ATPS) manufacturing platforms for the production of cephalexin, a generic cephalosporin antibiotic. Moreover, detailed comparisons of batch vs. continuous pharmaceutical manufacturing (CPM) for the ATPS protocol illustrate key benefits.