(696f) Supporting Commercial Scale Lyophilization Technology Transfers Using Experiments and Modeling

Typically, lyophilization cycles for pharmaceutical products are developed at lab scale due to many challenges associated with development at target scale (product limitations, costs, issues with timing, etc). However, because the heat and mass transfer properties that dictate the performance of the cycle are equipment-dependent (and particularly with the scale of the equipment), transferring a cycle developed at lab scale to commercial scale presents many new challenges that may detrimentally impact the product. This presentation explores how pairing select experiments with physics based and/or data-driven, statistical modeling can be used to support cycle transfer from lab scale to commercial scale ensuring robust, high quality product.