(211b) Progress on a Mixed-Mode Hydrogel Membrane – a New Tool for Mab Purification

In today’s high-titer biopharmaceutical mAb processes, there is a need for innovative separation approaches for capture or polish of biomolecules. Challenges exist, for example when the conductivity of the feed stream is high or when the aggregates level needs to be reduced immediately. Natrix is developing a mixed-mode chromatography membrane, which combines the properties of strong cation exchange and hydrophobic interaction. This mixed-mode chromatography membrane offers fast separation in a disposable format without sacrificing process performance. It opens up new opportunities for solving challenging purification problems as an alternative to conventional chromatography columns. This paper discusses the characteristics of the mixed-mode membrane together with performance across the design space to-date. The preliminary data shows high mAb binding capacity (up to 85 mg/mL), good clearance of HCP and aggregates at high conductivity (up to 15 mS/cm) and all at 6 seconds residence time. In addition, the low salt elution capacity (6 mS/cm) facilitates direct load onto a quaternary amine adsorber for mAb polishing.