The team developed a new type of intensified, continuous purification process that can meet the industry need by eliminating “Protein A” affinity chromatography, the bottleneck of the current “platform” mAb manufacturing process.
This new process employs:
The process can be operated in an integrated, fully continuous mode, increasing volumetric throughput while reducing buffer usage, cost-of-goods, and equipment and supply chain performance bottlenecks of Protein A-based mAb processing that limit global manufacturing capabilities.
Project steps included:
Will provide results needed to facilitate widespread industry adoption of this new process.
Will enable de-risking of an innovative recombinant protein purification process that is based on non-traditional continuous precipitation and flowthrough chromatography purification operations
Will offer relief from the capacity, buffer usage, cost, and supply chain bottlenecks of the current "platform" purification process for antibodies
Will reduce process and supply chain complexity rendering process suitable for global deployment, including low-resource environments
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