The Transition from Resin Chromatography to Membrane Adsorbers for Protein Separations at Industrial Scale

Abstract

ABSTRACT Membrane adsorbers (MA) are emerging as alternative unit operations in high-value protein separation due to their many benefits, including short residence times, low pressure drop, ease of scale-up and cost-effectiveness. Historically, the MA literature has been directed to new membrane materials and their use as a polishing step due to their low binding capacity. More recently, the emergence of membrane bind-elute modalities has extended their application at industrial scale, and a move from established resin chromatography to MA is feasible. To fill this gap and speed the development of MA, a review on the purification of monoclonal antibodies and other proteins in the pharmaceutical and food industries using commercially available MA and resin chromatography devices is presented. We compare MA with resins using three key criteria: product quality, industrial process feasibility and economic viability. In most studies, MA can produce comparable or even better product quality than resin chromatography. MA can be applied for multiple cycles within a single batch before disposal, leading to high productivity, savings from buffer consumption and the omission of cleaning verification. A cost analysis concludes that this approach can be more economical than resin chromatography.