Virtual process development using modeling & simulation: some examples

Synthetic molecules continue to play a major role in the development of treatments that benefit the lives of patients. However, the landscape of synthetic molecules has changed significantly over the last 30 years. From a rich small-molecule portfolio to a combination of small and medium size molecules, drug substance complexity, potency, and processing platforms have been evolving to adapt to the patient needs. Low volume/high potent/highly complex active ingredients define new design requirements. Practitioners responded to this trend by adopting advanced manufacturing approaches. This created the need for an interesting complementary that could speed up the discovery/development of novel drugs. Modeling and simulation started to gain traction.

This talk will describe the journey of drug substance process development through the lens of mechanistic models.

The advances made over the last few years are key for the development of new molecular entities and routine manufacturing of commercial medicines. This is showing to critical also to meet the need of ultra-rapid discovery, development, and manufacturing as a response to a biological threat such as COVID-19.