GORE: Building a Fully Single-Use Process

Recently,  AGC Biologics completed a study that explored the potential of intensified, fully single-use downstream processing for a monoclonal antibody (mAb) produced in a 2000 L single-use bioreactor. The focus is on the first use of Protein A membrane capture chromatography at a manufacturing scale, using GMP-compliant devices with high productivity. The use of single-use technologies in downstream processing is highlighted for its advantages, including reduced cleaning processes, quicker product changeovers, lower contamination risks, and decreased bioburden.

The traditional challenges in converting the affinity capture step to a fully utilized single-use operation are also discussed. Protein A affinity chromatography, a key step in downstream purification, has typically used resin beads with limitations in mass transport and operational pressure constraints. This study introduces membrane-based Protein A chromatography devices, specifically GORE® Protein Capture Devices with Protein A, to create a true single-use purification experience with higher productivity than standard resin columns.

The experimental setup involves a 500 L monoclonal antibody cell culture harvest processed in a 2000 L single-use bioreactor. The research showcases the high productivity, consistent yields, and low-leached Protein concentrations of these devices at Lab and manufacturing scales, in comparison with traditional resin columns.

The study further investigates downstream processes, including low pH viral inactivation, anion exchange chromatography, and tangential flow filtration, all utilizing single-use technologies. The results highlight successful purification, removal of impurities, and efficient utilization of GORE® Devices in a fully disposable production platform.