期刊
CURRENT OPINION IN CHEMICAL ENGINEERING
卷 34, 期 -, 页码 -出版社
ELSEVIER SCI LTD
DOI: 10.1016/j.coche.2021.100722
关键词
-
This review highlights the importance of bioprocess monitoring and control in the safe and effective manufacture of bioproducts, with a specific focus on the growing field of cell and gene therapy. The challenges and complexities of these products and the processes involved in their production are outlined, along with perspectives on implementation within the regulatory framework.
Bioprocess monitoring and control are an essential requirement for safe and effective manufacture of bioproducts. This review provides an overview of some of the latest developments in analytical techniques, process variability, monitoring and control approaches for biologics, with a specific emphasis on the growing sector of cell and gene therapy. The monitoring and control challenges arising from the broad range of cell and gene therapy products, the complexity of these products and the processes required to produce them are outlined. Perspectives and implementation challenges are then set in the context of the regulatory framework.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据