Lyo‑Modelling For Risk Reduction And Process Insights

Lyophilization is a critical technology for producing stable biopharmaceutical drug products, but its complexity makes process optimization challenging. This webinar provides a detailed look at how lyophilization modelling can improve process understanding and reduce risks along the path to commercialization. By simulating key aspects of the freeze‑drying cycle—particularly the primary drying phase, which is both the longest and most sensitive—predictive models help developers better understand temperature behavior, sublimation dynamics, and potential failure modes such as collapse, meltback, or choked flow.

View how robustness analysis enables assessment of parameter sensitivity, equipment variability, and material attributes, helping define acceptable operating ranges for chamber pressure and shelf temperature. These insights support more efficient process optimization, smoother scale‑up, and more reliable technology transfer. The webinar also addresses how statistical modeling approaches can balance process speed with product quality and prevent common issues encountered during primary drying.

Overall, the session demonstrates how integrating modelling and empirical validation accelerates development, enhances product consistency, and strengthens freeze‑drying strategies for complex formulations.