Impact of modeling and simulation on pharmaceutical process development

This paper explores recent advancements and future directions in the application of modeling and simulation for pharmaceutical process development. As the rising cost of drugs becomes a global concern, particularly in countries like Japan, where manufacturing costs and research and development (R&D) expenses significantly influence drug pricing, there is growing interest in leveraging digital technologies to enhance efficiency and reduce costs. While modeling and simulation hold promises for streamlining R&D and lowering manufacturing expenses, the full extent of their impact remains to be clarified. This paper discusses the key factors that must be considered to maximize their effectiveness, providing an overview of recent studies in three key modalities: small molecules, biopharmaceuticals, and regenerative medicine. The paper concludes by emphasizing the need for long-term investment to fully realize the potential of modeling and simulation in this field.