Principles and Practice of Lyophilization Process and Product Development: Scale-Up and Technology Transfer

Best practices for lyophilization cycle and product development, in both the development and manufacturing settings, are described here. Scale-up challenges associated with advancing the product from lab-scale setting to pilot-scale to commercial and even site-to-site transfer post launch are also discussed in greater detail. Specifically, the key scale-up issues associated with the freeze-drying process, namely, freezing, heat and mass transfer challenges, other scale-up factors such as time and measurement difference between different facilities and freeze dryers, etc., are highlighted along with recommendations to mitigate them. Finally, current approach for scale-up are shared along with next-generation PAT tools and approaches that may impart meaningful benefit over traditional approaches for cycle development and scale-up and/or complement the current approaches.