(235b) Breaking through the Limits of Chromatography Operations: Integration of a Novel Modular Chromatography Scaffold with Bed Design Features to Achieve High Speed and High Productivity

Much attention has been paid to the recent proliferation of new resin types such as protein A and mixed mode resins. Likewise there has been an increased focus on operating modes including SMB and multicolumn operations. All possess a variety of attributes that can affect purification operations and costs. However very little innovation has been made on the chromatography bed itself and how that can enhance productivity, affect resin usage and enable new operating domains. Additionally, very little innovation has been made in the design of the adsorptive device to enable simple and reliable scale-up from discovery to production scale. Chromassette® technology is a novel modular chromatography platform with a prepacked bed supported by an integral structural scaffold. Chromassette devices are linearly scalable chromatography columns in the form of a cassette. The supported bed enables operation at velocities exceeding 1000 cm/hr and high pressure pressure drops, further enabling smaller bead sizes and high speed operation even with compressible beads. Mechanistic modeling was used to identify the optimal design point of bed and bead resulting in 5-10 X productivity gains over current capture & release processes. The novel Chromassette device design will be reviewed along with results for protein A Mab capture and polishing. Future direction and possibilities of this new technology will also be illustrated.