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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Bibliographic Details
Published inComputer Aided Chemical Engineering Vol. 37; pp. 2177 - 2182
Main Authors Mortier, Séverine Thérèse F.C., Van Bockstal, Pieter-Jan, Nopens, Ingmar, Gernaey, Krist V., De Beer, Thomas
Format Book Chapter
LanguageEnglish
Published 2015
Subjects
Dynamic Design Space
Modelling
Optimization
Pharmaceuticals
Modelling
Optimization
Dynamic Design Space
Pharmaceuticals
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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.
ISBN:9780444634290
0444634290
ISSN:1570-7946
DOI:10.1016/B978-0-444-63576-1.50057-1