(207b) Platform Chemical Engineering Approaches to Support Manufacturing Optimisation

Pharmaceutical manufacturers are under ever-increasing pressure to continually improve process performance and robustness for products post-launch, due to both regulatory and economic pressures.  The application of fundamental engineering principles to the process at scale has the potential to realise significant improvements, often with the regulatory filing.  The key to capitalising on the potential for process improvement is to deepen the understanding of the process behaviour at scale.  In this talk, a number of case studies demonstrating the deployment of PAT, modelling and process control for post-launch optimization will be presented.  The case studies will focus on the engineering of particle attributes through control of the reaction and crystallization steps with the objective of improving downstream isolation and product performance.