Lyophilization: An industry perspective on the application of modeling to lyophilization process scale up and transfer

While freeze-drying modeling is well established and documented, the extent of its application to routine operations, including development and manufacture, has not yet been fully realized. A survey, conducted by  BioPhorum revealed that only a few companies use modeling for scale up and transfer. This paper outlines different applications of modeling to freeze-drying of biopharmaceutical products at commercial scale. It also signals the intent of  BioPhorum  to champion a wider adoption, and realize the full potential of modeling across the industry to standardize lyophilization practices, accelerate technology transfers and optimize operational performance