LYO Cycle Development Ensures Success For Oncology Drug Scale-Up

Scaling a lyophilized oncology drug from lab to production revealed excess moisture during validation, showing small‑scale conditions did not translate to larger systems. Engineers used bench data to rebalance the cycle, extending primary drying and reducing secondary drying. This maintained efficiency while improving moisture removal and consistency. The revised process achieved stable drying, passed validation, and ensured reliable, high‑quality manufacturing at larger scale.