Just released and available for download! Best Practices and Guidelines (2022) for Scale Up and Technology Transfer in Freeze-Drying Based on Case Studies. Part 2: Past Practices, Current Best Practices and Recommendations
Scale up and transfer of lyophilization processes remain very challenging tasks considering the technical challenges and the high cost of the process itself. The challenges in scale up and transfer were discussed in the first best practice paper, Best Practices and Guidelines (2022) for Scale-Up and Tech Transfer in Freeze-Drying Based on Case Studies. Part 1: Challenges during Scale Up and Transfer which includes vial breakage during freezing at commercial scale, cake resistance differences between scales, impact of differences in refrigeration capacities and geometry on the performance of dryers. Paper 1 has been accessed over 1700 times already and is available on open source at https://doi.org/10.1208/s12249-022-02463-x The second paper discusses successful and unsuccessful practices in scale up and transfer based on the experience of the 22+ authors, representing 13+ companies. Regulatory aspects of scale up and transfer of lyophilization processes were also outlined including a topic on the equivalency of dryers. Based on an analysis of challenges and a summary of best practices, recommendations on scale up and transfer of lyophilization processes are given including projections on future directions in this area of the freeze-drying field. Recommendations on the choice of residual vacuum in the vials were also provided for a wide range of vial capacities. Both of these papers were led by Serguei Tchessalov, Research Fellow at Pfizer, and were organized by a collaboration between LyoHUB and BioPhorum.
Thanks to the support of LyoHUB, this paper is available in open source and is available for download at https://link.springer.com/content/pdf/10.1208/s12249-023-02553-4.pdf