"Design of agarose-based chromatography resins for large-scale purification of monoclonal antibodies and other recombinant proteins."
Ponente: Hans J Johansson
The talk will cover design of resins for large scale chromatography processes. In downstream processing, research over the last decade has mainly been focusing on ligand design, different continuous solutions and non-bead formats such as membrane and, nano-fiber technology. However, the work horse of today’s clinical and commercial processes is still porous resins based on styrenic, acrylic, or agarose chemistry. These beads have been produced by the same batch emulsification methodology since the mid-half of the last century. The resulting resins have a very wide particle size distribution (PSD) requiring extensive screening to achieve the column performance demanded in modern processes. In contrast, by utilising a scalable continuous emulsification technology termed “jetting”, agarose beads with a significantly narrower PSD have been manufactured. The technology omits the need for sieving, and results in almost quantitative yield. Jetted uniform beads used for design of Protein A resins have shown very high dynamic binding capacities, 70-80 mg/ml, and pressure flow characteristics relevant for large scale chromatography.
In this presentation the impact of resin design on performance characteristics such as capacity, resolution, pressure flow, and packing reproducibility will be discussed. Protein A affinity chromatography is used in the absolute majority of mAb downstream processes. It also known as being the most expensive unit operation. The combination of new resins and cost-effective process designs can bring down the cost by more than 50 %.