Analysis of the crystallization process of a biopharmaceutical compound in the presence of impurities using process analytical technology (PAT) tools
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- 作者：Elena Simone ; Wei Zhang and Zoltan K Nagy
- 关键词：PAT tools ; biopharmaceutical ; vitamin ; crystallization ; monitoring
- 刊名：Journal of Chemical Technology & Biotechnology
- 出版年：2016
- 出版时间：May 2016
- 年：2016
- 卷：91
- 期：5
- 页码：1461-1470
- 全文大小：2395K
- ISSN：1097-4660
文摘
The crystallization of biopharmaceuticals can be problematic since, because the biosynthesis of these compounds is very difficult to control, they can contain a significant amount of impurities that have to be eliminated. In fact, impurities can lead to changes in the properties of the drug that can significantly reduce its effectiveness or even put the user in danger. The aim of this work is to exploit process analytical technology (PAT) tools to study the crystallization step of vitamin B12 crude product extracted via fermentation.