A Methodical Approach to Ultra-Scale-Down of Process Sequences: Application to Casein Removal from the Milk of Transgenic Animals

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• 作者：Lars W. Pampel ; Rihab Boushaba ; Nigel J. Titchener-Hooker
• 刊名：Biotechnology Progress
• 出版年：2008
• 出版时间：February 2008
• 年：2008
• 卷：24
• 期：1
• 页码：192 - 201
• 全文大小：171K
• 年卷期：v.24,no.1(February 2008)
• ISSN：1520-6033

文摘

Scale-down models of individual operations are widely used in biopharmaceutical processdevelopment to obtain information about the performance of production-scale equipment on thebasis of inexpensive and efficient laboratory-scale tests, for the purposes of validation oroptimization or characterization studies. We have investigated the ability of scale-down modelsof whole process sequences to provide reliable information for process scale-up from laboratory-to pilot-scales of operation. Using the example of the recovery of a protein from transgenicmilk, we have conducted an a priori scale-down analysis of a projected pilot-scale processsequence. A systematic approach was developed to ensure that all critical aspects of processbehavior were included in the scale-down model, resulting in the creation of an accurate andreliable scale-down representation of the pilot-scale process. The data from scale-down processtrials conducted at 70 and 200 mL scales of operation served to highlight crucial factorsdetermining process performance, and proved reliable in predicting the performance of the pilot-scale process over a scaling factor of 1000.