ABSTRACT
Protein Removal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 241 7.4 Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 243 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 243
Chromatographic unit operations have become universal in biopharmaceutical purification processes. No other type of unit operation can compare with chromatography in terms of its ability to achieve the purities required for injectable biopharmaceuticals [1,2]. Chromatographic steps exist in a variety of modes based on the type of functional group attached to the
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by the of the base matrix itself interacting with solutes through secondary interactions [3], ligand density of the functional groups, spacer chemistry, pore structure, and mass transport properties of the adsorbent. Selecting the best resin not only assures a reliable separation, but can also go a long way toward assuring process robustness and creating better process economics. However, the process of resin screening can be tremendously time-and resource-intensive if one seeks to explore all possible combinations of operating parameters and chromatographic stationary phases. In addition to selectivity for a given separation, a variety of other performance attributes (e.g., pressure flow characteristics, column lifetime, cleaning, and sanitization) are considered during resin selection. Clearly, the development of effective and resource efficient strategies for resin screening is an important component of bioprocess development.
