A multidisciplinary approach was utilized to develop a mechanistic kinetic model of a continuous silylation reaction within a drug substance chemical synthesis. Analysis by mid-infrared spectroscopy and 1H and 29Si-NMR were both valuable monitoring tools toward obtaining insight into the reaction kinetics.
A multi-step kinetic mechanism was proposed based upon the experimentation and orthogonal simulation results. The impact of reaction temperature, solvent concentration, and recipe were investigated. The model has been applied to both batch and continuous processes. Discussion will include sharing key learning from the model development and its application toward risk management and understanding the feasible operating region.
See more of this Session: Model Based Integrated Design of Pharmaceutical Drug Substance Processes I
See more of this Group/Topical: Pharmaceutical Discovery, Development and Manufacturing Forum
See more of this Group/Topical: Pharmaceutical Discovery, Development and Manufacturing Forum