Model-based optimization of the primary drying step during freeze-drying

被引:0
作者
Mortier, Severine Therese F. C. [1 ,2 ]
Van Bockstal, Pieter-Jan [2 ]
Nopens, Ingmar [1 ]
Gernaey, Krist V. [3 ]
De Beer, Thomas [2 ]
机构
[1] Univ Ghent, BIOMATH, Dept Math Modelling Stat & Bioinformat, Fac Biosci Engn, B-9000 Ghent, Belgium
[2] Univ Ghent, Lab Pharmaceut Proc Analyt Technol, Dept Pharmaceut Anal, Fac Pharmaceut Sci, B-9000 Ghent, Belgium
[3] Tech Univ Denmark, CAPEC PROC, Dept Chem & Biochem Engn, DK-2800 Lyngby, Denmark
来源
12TH INTERNATIONAL SYMPOSIUM ON PROCESS SYSTEMS ENGINEERING AND 25TH EUROPEAN SYMPOSIUM ON COMPUTER AIDED PROCESS ENGINEERING, PT C | 2015年 / 37卷
关键词
Dynamic Design Space; Modelling; Optimization; Pharmaceuticals;
D O I
暂无
中图分类号
TQ [化学工业];
学科分类号
0817 ;
摘要
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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收藏
页码:2177 / 2182
页数:6
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