A NOVEL ANION-EXCHANGE RESIN SUITABLE FOR BOTH DISCOVERY RESEARCH AND CLINICAL MANUFACTURING PURPOSES

Abstract

Strong ion-exchange protein chromatography is one of the most powerful and most common steps for protein purification in both discovery research and manufacturing. However, the demands on protein purification of early drug discovery and later stage manufacturing are quite different. In order to shorten the time of developing a purification process for new protein drug candidates, there is a need for a strong ion-exchange resin that will be optimum for both stages. This article details a novel anion-exchange resin suitable for research, as well as for clinical manufacturing. In this study, a novel Q resin anion-exchange prototype was evaluated and compared to the GE Healthcare Q Sepharose® Fast Flow (QFF) and Q Sepharose® High Performance (QHP) resins. This study specifically focused on the following: resolution, dynamic binding capacity, flow rate, back pressure, and scale up. The evaluation was performed in both small- and large-scale experiments. From all the comparable data, the prototype resin is adaptable for both discovery research and manufacturing. Its wide-range operation suitability could potentially shorten the time required to develop conventional purification protocols for clinical manufacturing.