期刊
CURRENT OPINION IN BIOTECHNOLOGY
卷 53, 期 -, 页码 76-84出版社
ELSEVIER SCI LTD
DOI: 10.1016/j.copbio.2017.12.015
关键词
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With the growth of our understanding of biopharmaceutical processes, a transition from classical batch to continuous integrated manufacturing of therapeutic proteins is taking place across laboratory, clinical and commercial scales. Encouraged by regulatory authorities, this transition is favoured by new emerging technologies as well as by the development of better simulation models. The current status of continuous cell culture and downstream processes and requirements for their successful integration are discussed in this article, with specific reference to product quality attributes.
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