The Journey of Mechanistic Models from Design to Optimization/ Launch… and Beyond

This work describes a diversity of technical needs that led to the development of several mechanistic models to guide the design of specific drug substance processes at early phases of development. Some of these former models were also used for process optimization to define design spaces, predict process acceptable ranges and normal operating ranges and define conditions for process validation. Considerations on the requirements for models classified as medium impact and the approach to include mathematical expressions in the common technical document will be discussed. Finally, some details on the planned integration of mechanistic models to the manufacturing environment post-validation will be provided.