(463a) Digital Applications of Mechanistic Models in Pharmaceutical Operations

In the past decade, application of mechanistic models in pharmaceutical research and development has become an industry-standard approach to accelerate pharmaceutical development timelines, assess and mitigate risks, and support scale up and tech transfer. More recently, the advent of industry 4.0 has spread to the pharmaceutical industry, leading to a rise of digitalization efforts to modernize pharmaceutical manufacturing operations. Along with the increasing availability of digital technologies, this trend has inspired applications of mechanistic models in pharmaceutical operations for real-time process optimization, operator training, soft sensing and advanced monitoring. In this talk, highlights of recent digital applications of mechanistic models across the pharmaceutical lifecycle will be presented. Case studies will include solvent swap process optimization, soft sensing of a fluid bed granulation process, and operator training for a continuous direct compression process.