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 part of this paper and include vial breakage during freezing at commercial...

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Published in:AAPS PharmSciTech 2023-04, Vol.24 (4), p.96-96, Article 96
Main Authors: Tchessalov, Serguei, Shalaev, Evgenyi, Bhatnagar, Bakul, Nail, Steven, Alexeenko, Alina, Jameel, Feroz, Srinivasan, Jayasree, Dekner, Michael, Sahni, Ekneet, Schneid, Stefan, Kazarin, Petr, McGarvey, Orla, Van Meervenne, Bert, Kshirsagar, Vaibhav, Pande, Paritosh, Philipp, Jens, Sacha, Greg, Wu, Ke, Azzarella, Joseph, Shivkumar, Gayathri, Bhatt, Shreyas, Mehta, Shyam B.
Format: Article
Language:English
Subjects:
Biochemistry
Biomedical and Life Sciences
Biomedicine
Biotechnology
Freeze Drying
Pharmacology/Toxicology
Pharmacy
Research Article
Technology Transfer
Technology, Pharmaceutical
Temperature
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Summary: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 part of this paper and include 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. The second part of this work discusses successful and unsuccessful practices in scale-up and transfer based on the experience of the authors. 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. Graphical Abstract
ISSN:1530-9932
1530-9932
DOI:10.1208/s12249-023-02553-4