Question
You are developing a size exclusion chromatographic purification step for a protein drug. You have packed a 60 cm long column with a commercial gel
You are developing a size exclusion chromatographic purification step for a protein drug. You have packed a 60 cm long column with a commercial gel filtration resin. To characterize the column performance, you run human serum albumin, as a test protein, through the column and find that it has a retention volume of 80 mL , a peak width of 16 mL , and an estimated partition coefficient of 0.52. Based on information provided by the manufacturer, you know that the intra-particle pore volume of the resin is 84mL . You have previously worked with this chromatographic resin, and know that the target biologic typically has a partition coefficient of 0.4 and the major protein impurity has a partition coefficient of 0.68. Given this information, what do you expect the peak resolution to be between the target protein and the major protein impurity? Answer to two decimal places.
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