The pharmaceutical and biopharmaceutical industry stands as a unique sector, driven by great innovation yet bound by deep-rooted conservatism. The discovery and manufacture of novel drugs and therapies unfold within a highly regulated environment that both safeguards and constrains technological progress. For decades, Process Systems Engineering (PSE) was perceived as a niche discipline, with its relevance to pharmaceutical development often questioned. The advent of the Quality-by-Design initiative, however, marked a paradigm shift opening the door to systematic process modelling and optimization, advanced monitoring and control, and more recently, to data-driven approaches leveraging machine learning and artificial intelligence.
Drawing primarily on the speaker’s personal experience, this talk will explore how PSE methods have been applied to pharmaceutical and biopharmaceutical systems, emphasising what distinguishes this field from more conventional process industries. The presentation will also reflect on emerging challenges and opportunities: on the one hand, those arising from the rapid evolution of complex biopharmaceutical products, and on the other hand, those enabled by the powerful tools now available to the PSE community.
