Continuous Countercurrent Spiral Chromatography (CCSC) – Feasibility, Demonstration and Commercialization

Development of a new device format called the spiral sorter into process development within the CCTC framework.

Project status

100% Completed

Solution

Performance Period: 1/15/2020 to 5/31/2021

ChromaTan has developed Continuous Countercurrent Tangential Chromatography (CCTC) to overcome the limitations of traditional column chromatography. Although CCTC has shown outstanding performance for fed-batch continuous downstream operations, further development is needed for long-term continuous processing. The objective of this project is to commercialize a new device format called the spiral sorter into process development within the CCTC framework by utilizing additive manufacturing tools, hydrodynamic modeling, scale up, pilot scale Protein A antibody capture campaigns and economic analysis. We project that this new approach (CCSC) would save end-users 70-80% off their clinical purification costs and enable robust and steady-state continuous purification for long-term operations. The proposed 1-year effort will evolve manufacturing readiness level of this technology from MRL 4 to MRL 5. The deliverables of the projects if successful will be used for a larger multi-organizational proposal that will evolve the technology from MRL 5 to MRL 8.

Impacts

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.

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.