In this presentation we discuss an approach for the commercial formulation development of a mAb using both empirical and DOE studies. In addition to using conventional biochemical techniques to monitor stability at accelerated conditions, we evaluated colloidal properties and inherent protein stability to assess solvent mediated interactions. Here we describe the utility of solution stability measurements to quickly select a formulation during commercial development.

Commercial antibody formulation development using quality by design elements

251st National Meeting (2016)

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