WuXi Biologics, a global leading open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing based in, and its partner Pall Corporation, the global leader of advanced filtration, separation and purification technologies, established a joint laboratory to develop full continuous processing for the manufacturing of monoclonal antibodies (mAb).
The 3-year project started with the continuous operation of individual processes and will gradually be expanded to downstream processing development and production. The joint laboratory will serve WuXi Biologics’ customers worldwide in an attempt to significantly reduce mAb drugs’ manufacturing costs and benefit patients around the world.
The joint laboratory, constructed with Pall Life Sciences’ unique CadenceTM Integrated Continuous Bioprocess System and integrated with its single-use technology platform, ensures process flexibility, facilitates switches between processes and avoids cross-contamination, thereby enabling pharmaceutical companies to reduce the manufacturing space required at a facility and to reduce cost.
After years of intensive efforts on technological development, WuXi Biologics has developed high-yielding cell lines and laboratory-scale continuous processes, significantly increasing the expression of some mAbs to up to equivalent of 40-50 g/L in the traditional fed-batch process, which is approximately 10 times more productive than the typical fed-batch process. Moving forward, the teams will improve large-scale purification equipment and technology that often becomes a bottleneck in continuous processing and will work to resolve the bottleneck. With this joint laboratory, WuXi Biologics plans to soon expand the continuous process scale to 500 L and reduce mAbmanufacturing cost to 30-50 USD/g, and then scale up to 1000 L and further reduce costs to less than 15 USD/g.
“WuXi Biologics is committed to further accelerating our expansion in capabilities and capacities, strengthening our leadership position as the most comprehensive and integrated enabling platform, empowering anyone and any company to discover, develop and manufacture biologics,” said Dr. Chris Chen, CEO of WuXi Biologics. “The partnership with Pall helps us utilize the global innovation and leading technology to effectively resolve bottlenecks of continuous processing, to significantly lower the cost of biologics and benefits patients worldwide.”