Modeling of Purification Operations in Biotechnology: Enabling Process Development, Optimization, and Scale-Up

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• 作者：Ajoy Velayudhan ; Manoj K. Menon
• 刊名：Biotechnology Progress
• 出版年：2007
• 出版时间：February 2007
• 年：2007
• 卷：23
• 期：1
• 页码：68 - 73
• 全文大小：42K
• 年卷期：v.23,no.1(February 2007)
• ISSN：1520-6033

文摘

Process modeling involves the use of a set of mathematical equations to represent key physicalphenomena involved in the process. An appropriately validated model can be used to predictprocess behavior with limited experimental data, identify critical ranges for process variables,and guide further process development. Although process modeling is extensively used in thechemical process industries, it has not been widely used in purification unit operations inbiotechnology. Recent FDA guidelines encourage the use of process modeling during processdevelopment, along with multivariate statistical methods, detailed risk assessment, and otherquantifiers of uncertainty. This paper will review recent advances in the modeling of keydownstream unit operations: chromatography, filtration, and centrifugation. The focus will beon the application of modeling for industrial applications. Relevant papers presented at a sessionon this topic at the recent American Chemical Society National Meeting in San Francisco willalso be reviewed.