Model-based optimization of the primary drying step during freeze-drying
Since large molecules are considered the key driver for growth of the pharmaceutical industry, the focus of the pharmaceutical industry is shifting from small molecules to biopharmaceuticals: around 50% of the approved biopharmaceuticals are freeze-dried products. Therefore, freeze- drying is an imp...
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Published in | Computer Aided Chemical Engineering Vol. 37; pp. 2177 - 2182 |
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Main Authors | , , , , |
Format | Book Chapter |
Language | English |
Published |
2015
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Subjects | |
Online Access | Get full text |
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Summary: | Since large molecules are considered the key driver for growth of the pharmaceutical industry, the focus of the pharmaceutical industry is shifting from small molecules to biopharmaceuticals: around 50% of the approved biopharmaceuticals are freeze-dried products. Therefore, freeze- drying is an important technology to stabilise biopharmaceutical drug products which are unstable in an aqueous solution. However, the freeze-drying process is an energy and time-consuming process. The use of mechanistic modelling to gather process knowledge can assist in optimisation of the process parameters during the operation of the freeze-drying process. By applying a dynamic shelf temperature and chamber pressure, which are the only controllable process variables, the processing time can be decreased by a factor 2 to 3. |
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ISBN: | 9780444634290 0444634290 |
ISSN: | 1570-7946 |
DOI: | 10.1016/B978-0-444-63576-1.50057-1 |