Purification Process Development with Monoliths: I. Initial Screening

P. Gagnon

Roadmap to Process Development, issue 1/2009, BIA Separations

Introduction

Commercial purification process development involves harmonizing a complex hierarchy of safety, regulatory, and economic considerations with the unique physicochemical characteristics of the product and the suite of contaminants that must be removed. This can be challenging even with product classes that exhibit fairly consistent chromatographic behavior, such as IgG monoclonal antibodies. It is even more demanding with products that do not support a platform approach. In either case, process development requires detailed knowledge of how the product behaves relative to contaminants within the operating ranges of the methods that may be used in its purification. This knowledge can be obtained only by characterizing product retention experimentally, a process that begins with initial screening. Screening produces the first indications of what methods offer the most promising fractionation capabilities, under what conditions, and in what order different methods may be linked together to yield an integrated multi-step purification procedure.