Abstract:
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Hydrophobic interaction chromatography (HIC) is a useful separation technique employed in manufacturing processes for protein therapeutics. HIC separates proteins from one another based on their properties of hydrophobicity, thus purifying proteins while maintaining the biological activity under certain conditions. Our interest is to study protein behavior in HIC and get the optimal conditions of HIC. Design of Experiment (DOE) is the most efficient way to solve this optimization problem during process development. An additional goal of this study is to compare multiple different types of DOEs including two Resolution III fractional factorial designs, two Resolution IV fractional factorial designs, Plackett-Burman design and definitive screening design. The comparison has two aspects. First, we illustrate the basic statistical properties of each design type. Second, the comparison is based on the optimization results of this real HIC example.
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