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The companies have established a joint laboratory to develop full continuous processing to manufacture high yields of monoclonal antibodies at reduced costs.
WuXi Biologics, a Hong Kong-based open-access biologics technology platform company, and its partner Pall Corporation, a provider of advanced filtration, separation, and purification technologies, established a joint laboratory on Nov. 2, 2017 to develop full continuous processing to manufacture monoclonal antibodies (mAbs).
The three-year project, which started with the continuous operation of individual processes, will gradually be expanded to downstream processing development and production and will attempt to significantly reduce manufacturing costs for mAb-based drugs. The joint laboratory was constructed with Pall Life Sciences’ Cadence integrated continuous bioprocess system and integrated with its single-use technology platform. The lab ensures process flexibility, facilitates switches between processes, and avoids cross-contamination, which enables the reduction of manufacturing space required at a facility and can thus reduce cost.
WuXi Biologics has developed high-yielding cell lines and laboratory-scale continuous processes over the years and has significantly increased the expression of some mAbs to up to equivalent of 40-50 g/L in the traditional fed-batch process, approximately 10 times more productive than the typical fed-batch process.
Moving forward, the companies will improve large-scale purification equipment and technology that is often the source of bottlenecking in continuous processing and will work to resolve the bottleneck. WuXi Biologics plans to soon expand the continuous process scale of the joint laboratory to 500 L and reduce mAb manufacturing cost to $30-50/g. The company then plans to scale up to 1000 L and further reduce costs to less than $5/g.
Source: WuXi Biologics