Novel Protein A Chromatography for Single-Use Facilities

Single-use technology has become increasingly popular in both upstream and downstream biopharmaceutical manufacturing. While there has been substantial adoption of upstream single-use technologies, there continues to be a lag in the development and adoption of single-use technologies in downstream – particularly in chromatography. To help achieve the vision of a completely disposable & flexible manufacturing platform, Grace has developed new high capacity pre-packed disposable protein A columns. The new columns integrate the technologies of Grace silica & surface chemistry with those of Repligen’s rSPA & OPUS® columns. The unique element of the product lies in the optimization of silica and bonding chemistry to maximize dynamic binding capacity while controlling non-specific protein binding. Furthermore, the product demonstrates stability to caustic cycling within a single-campaign use. Most importantly, the incompressible silica substrate ensures scalable performance regardless of column size & flow rates allowing for further productivity improvements in purification run times. Overall, this plug-and-play single-use chromatography solution represents the missing link in enabling a fully disposable MAb manufacturing platform.