Digital Twins and AI Reshape Biopharmaceutical Manufacturing
The foundation of any control strategy is process understanding. And, according to the ICH’s Q8 guidance,1 modeling is the best way to generate process understanding and meet regulators’ quality-by-design expectations. The models should describe the relationship between process parameters and drug quality and performance attributes.
Statistical models—predictions based on available data—have proven to be the most popular approach so far. Many manufacturers have used data-based models to guide development, scale-up, and process control. But their predictive power is limited to the range of data available, and they require significant experimental effort.
For this reason, mechanistic models—assumptions based on known principles rather than just data—are gaining in popularity. Mechanistic models “can provide a full description of the system, higher prediction power, as well as the potential to extrapolate well outside of calibration space,” Li explains. “They are valuable tools for predicting scale-up process performance, thereby de-risking large-scale manufacturing runs.”