A perspective on PSE in pharmaceutical process development and innovation

The pharmaceutical industry is under growing pressure to increase efficiency, both in production and in process development. This paper discusses the central role of Process Systems Engineering (PSE) methods and tools in pharmaceutical process development and innovation, and searches for answers to questions such as: Which PSE methods can be applied readily? Where is more method development needed? The paper covers key subjects for development of economically and environmentally sustainable pharmaceutical processes, including Process Analytical Technology in its broadest sense, continuous pharmaceutical manufacturing and green processes, and is illustrated with a series of short examples taken from the literature and ongoing research projects.