Protein A chromatography is effective for mAb recovery and impurity removal without pretreatment. However, it has drawbacks like high resin costs, low productivity, and complex column packing and cleaning. Advances in cell culture have increased mAb titers, shifting bottlenecks to downstream operations and highlighting the need for innovation in mAb capture.
The project goal is to develop and implement a
novel Protein A chromatography system using a 3D printed spiral sorter specifically designed for long-term continuous operation for use as part of an integrated continuous biomanufacturing process.
Development of the Spiral Sorter CCTC platform will decrease the amount of expensive resin needed for clinical manufacturing by 80%, enabling quick-to-launch flexible facilities to make life-saving therapies with a faster turnaround.
Development of 3D printing manufacturing capability for Spiral Sorters will enable rapid and flexible manufacturing of customized single-use parts for bioprocessing applications.
The Spiral Sorters will complement regulatory initiatives to decrease risk and increase product quality by limiting the amount of manual single-use assembly that can result in leaks and contamination.
Two geometries were evaluated for the spiral sorter design.
Able to achieve separation efficiencies of 75-85% at conditions that are realistic to CCSC operation.
Continuous Countercurrent Spiral Chromatography (CCSC) – Feasibility, Demonstration and Commercialization (PC2.2-157), NIIMBL Member Forum, Virtual, January 28, 2021.
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ChromaTan Corporation
Genentech, Inc.
Merck Sharp & Dohme LLC
The Pennsylvania State University
