Application of first principles primary drying model to lyophilization process design and transfer: case studies from the industry

This paper acts as a pathway to share the collective knowledge of industry models and accelerate their adoption. Written by BioPhorum’s Lyophilization Workstream, the paper is supported by detailed tabular and graphical data and includes a spreadsheet tool that presents fresh examples to introduce the process of modeling the primary drying phase. 

The model described in the paper provides a greater understanding of a primary drying process and shows how to reduce some of the significant cost and resource burdens associated with multiple commercial-scale trials. The model can enable faster product development, deviation analysis and efficient technology transfer activities. 

The paper’s case studies highlight the tangible benefits that companies have realized. They also demonstrate the robustness and flexibility of the model in predicting the primary drying parameters in completely different settings, such as formulations, equipment, primary containers, etc.

Published in the Journal of Pharmaceutical Sciences, the paper builds on a previous BioPhorum presentation called An industry perspective on the application of modeling to lyophilization process scale-up and transfer. This highlighted the benefits of a model-based understanding of the primary drying process in various pharmaceutical settings and at different stages of development, technology transfer and manufacturing.