Development Of Biopharmaceuticals Requiring Lyophilized Formulations

By Emily Gong and William Kessler

Technology transfer of lyophilization cycles from laboratory to production-scale dryers typically involves preserving product temperature histories. This is usually accomplished by maintaining the same drying chamber pressure setting and adjusting the shelf temperatures and drying times. This study focuses on demonstrating the application of the LyoCapsule™ Freeze Dryer for emulating product temperature history between two laboratory dryers using adjustments to the radiation environment in the LyoCapsule™ Freeze Dryer to emulate center and edge vial drying conditions in the LyoStar 3 Freeze Dryer. Vials in both dryers were exposed to similar particle-laden environments, likely resulting in similar product resistance to drying values (although these have not yet been assessed).