Streamlining Sanofi's Process Modeling for Drug Substance Manufacturing for Scale-Up Success
Optimize Batch and Continuous Manufacturing Operations
Programme
- How to characterize a T3P-mediated amidation reaction with extremely fast kinetics.
- How reaction modeling insights inform the design of a pilot-scale continuous tubular reactor.
- How to leverage METTLER TOLDEO advanced PAT by integrating in-situ FTIR, HPLC, and kinetic modeling.
This presentation highlights the reaction characterization stage of a comprehensive digital-twin development workflow for the continuous manufacturing of an API from Sanofi’s small-molecule portfolio. Specifically, a T3P-mediated amidation reaction is investigated by combining in-situ FTIR, offline HPLC, and kinetic modeling techniques. This integrated approach revealed a previously unrecognized multi-step acid activation mechanism and enabled the kinetic modeling of extremely fast elementary reactions. The proposed mechanism informed optimal strategies for the design of a pilot-scale continuous tubular reactor, including reagent addition sequence and optimal residence times. The calibrated kinetic model ultimately provides the foundation for a systems-level model to support the design and control of a continuous synthesis process for a Sanofi API.
About the Presenter
Reza Amirmoshiri, Ph.D.
Principal Scientist in Drug Substance Process Engineering, Sanofi
Reza Amirmoshiri is a Principal Scientist in the Process Engineering team within Sanofi’s Synthetic CMC Development organization. He specializes in pharmaceutical manufacturing process development, with expertise in system model development and deployment, soft sensing, and advanced process monitoring and control.
