The proposed presentation “Linking molecules to manufacturing - kinetic and engineering approaches” will highlight the critical role played by process engineers in addressing robustness and scale-up challenges associated with reactions and downstream operations in drug substance manufacturing. Case studies highlighting the application of suitable kinetic and engineering approaches through various stages of process development will be shared. Drawing on industry examples, strategic selection of manufacturing equipment based on operational capabilities and process characteristics for technology transfer and validation will be discussed. Critical role played by predictive models to understand and predict influence of mass/heat transfer and operational characteristics of manufacturing plant will also be presented.
