How to Beat the Bottleneck
As the accelerating number of monoclonal antibodies on the market continues to drive higher upstream titers, chromatography resin suppliers must continually strive to improve productivity, quality and overall process economy.
sponsored by GE Healthcare
The monoclonal antibody (mAb) field has come a long way since the first therapeutic mAb was commercialized in 1986. As of today, over 60 mAbs have been approved in the US and Europe and sales of mAbs are expected to cross $125 billion by 2020 (1). As the number of mAbs on the market and in development has accelerated over the years, so too have upstream titers. With the increasing upstream titers, the constraints on downstream processing have only increased. The efficient recovery and purification of mAbs from cell culture medium is a critical part of the production process and can contribute significantly to the total manufacturing costs (2). Protein A affinity chromatography is commonly used in the process-scale purification of mAbs because it is an easy, fast and selective procedure for capturing the target protein – often resulting in a greater than 99 percent purity from complex cell culture media in a single step.
The demands of protein A resins have evolved significantly over the years and the nature of the process means that the capture step can act as a bottleneck – especially as upstream titers continue to increase. I believe suppliers must do what they can to keep pace with the constantly evolving demands of the industry. And this is why GE Healthcare Life Sciences has made the long-term strategic decision to constantly improve our protein A chromatography resins.
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