Modelling and synthesis of pharmaceutical processes: moving from batch to continuous

ABSTRACT

Research in pharmaceutical process development has gained a lot of interest over the last years. Long development times, increasing R&D costs, increasing competition, and short patent duration are some of the driving forces for the increased research efforts in the field. Increased process understanding of the pharmaceutical process has resulted in major improvements in the field. Process systems engineering (PSE) approaches, which have been successfully applied in the design, analysis and optimization of chemical and petrochemical processes, might be also important for the improvement of pharmaceutical processes by providing systematic and structured solutions for the stages of the pharmaceutical process development.

In this PhD thesis, the objective is to systematize the pharmaceutical process development in order to enhance process understanding by creating a data-rich environment and to investigate/evaluate opportunities for continuous operation. To achieve the mentioned objectives the use of an integrated framework based on systematic model-based methods and tools is proposed. Computer-aided methods and tools are used to generate process knowledge and to evaluate different operational scenarios.