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首页> 外文期刊>Biotechnology Progress >A Methodical Approach to Ultra-Scale-Down of Process Sequences:Application to Casein Removal from the Milk of Transgenic Animals
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A Methodical Approach to Ultra-Scale-Down of Process Sequences:Application to Casein Removal from the Milk of Transgenic Animals

机译：一种超缩减工艺顺序的方法学方法：在酪蛋白从转基因动物乳中去除中的应用

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摘要

Scale-down models of individual operations are widely used in biopharmaceutical process development to obtain information about the performance of production-scale equipment on the basis of inexpensive and efficient laboratory-scale tests,for the purposes of validation or optimization or characterization studies.We have investigated the ability of scale-down models of 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 transgenic milk,we have conducted an a priori scale-down analysis of a projected pilot-scale process sequence.A systematic approach was developed to ensure that all critical aspects of process behavior were included in the scale-down model,resulting in the creation of an accurate and reliable scale-down representation of the pilot-scale process.The data from scale-down process trials conducted at 70 and 200 mL scales of operation served to highlight crucial factors determining process performance,and proved reliable in predicting the performance of the pilot-scale process over a scaling factor of 1000.
机译：个体操作的按比例缩小模型广泛用于生物制药工艺开发中，目的是在进行廉价或高效的实验室规模测试的基础上获取有关生产规模设备性能的信息，以进行验证或优化或表征研究。研究了整个过程序列的缩减模型为从实验室规模扩大到中试规模的过程提供可靠信息的能力。以从转基因牛奶中回收蛋白质为例，我们进行了先验预计的中试规模过程序列的按比例缩小分析。开发了一种系统方法来确保过程行为的所有关键方面都包括在按比例缩小模型中，从而创建了准确而可靠的按比例缩小表示形式在70和200 mL的操作规模下进行的按比例缩小过程试验获得的数据突出显示了c决定过程性能的重要因素，并证明在预测比例因子1000时的中试规模过程的性能可靠。

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