Author:
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
Abstract
AbstractThe freeze-drying process scale-up and transfer remain a complicated and non-uniform practice. We summarized inefficient and good practices in these papers and provided some practical advice. It was demonstrated that using the same process set points/times in laboratory and commercial scale dryers may lead to loss of product quality (collapse or vial breakage). The emerging modeling approach demonstrated practical advantages. However, the upfront generation of some input parameters (vial heat transfer coefficient, minimum controllable pressure, and maximum sublimation rate) is essential for model utilization. While the primary drying step can be transferred with a high degree of confidence (e.g., using modeling), and secondary drying is usually fairly straightforward, predicting potential changes in product behavior during freezing remains challenging.
Graphical Abstract
Publisher
Springer Science and Business Media LLC
Subject
Drug Discovery,Pharmaceutical Science,Agronomy and Crop Science,Ecology,Aquatic Science,General Medicine,Ecology, Evolution, Behavior and Systematics
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