Leveraging Single-Use Technologies And Membrane-Based Protein A Chromatography To Revolutionize Antibody Manufacturing

By Shunsuke Shiina, Ph.D., Chase Snyder, Neha Saxena, Ph.D., and Rodrigo Gonzalez, Ph.D, AGC Biologics

Single-use technologies are transforming the downstream processing of antibody-based therapeutics, offering several advantages over traditional methods. They can reduce labor-intensive cleaning processes, decrease product changeover times, and minimize bioburden. For instance, single-use membrane-based Ion Exchange Chromatography (IEX) columns and Tangential Flow Filtration (TFF) systems have demonstrated superior performance compared to their traditional counterparts.

However, the affinity capture step in downstream processing has presented difficulties when converting projects to a high-productivity, fully utilized single-use operation. Ideally, the performance characteristics of membrane chromatography columns should be capable and scalable from drug discovery and process development through manufacturing scale.

Membrane-based Protein A chromatography columns are emerging as a promising alternative, offering significantly higher productivity. These columns enable smaller bed volumes to be cycled to full capacity, reducing resin waste and associated costs. GORE® Protein Capture Devices with Protein A incorporate a composite membrane enabling high binding capacity at fast flow rates. This study demonstrates the feasibility of a fully single-use downstream process for a monoclonal antibody (mAb) at industrial scale. Using parallel manifold Gore 1 Liter Devices, the study successfully purifies a 500 L antibody harvest, paving the way for a full 2000 L batch.

Learn how a fully disposable upstream and downstream platform process in antibody production can increase production timelines, enhance scalability, and reduce risk in biologics manufacturing, ultimately increasing productivity.