We are developing proprietary equipment & a de novo, end-to-end process for biopharmaceutical manufacturing
- Cell line development to enable long-term cell culture growth capabilities to support high, sustained mAb titres throughout continuous production.
- Specialized media development to support the long-term cell culture demands.
- Adaptation of chemostat or perfusion bioreactors to enable long-term, continuous mAb production.
- The development of a small footprint, modular downstream process to enable continuous purification and to offer flexibility in desired process flow to support the needs of a diverse set of products.
The purification modules are designed to:
- Be connected to continuously purify monoclonal antibodies (and other protein therapeutics) based on their intrinsic structural and biophysical properties (e.g. hydrodynamic size, hydrophobic character, electrostatic character);
- Replace centrifugation and depth filtration processes; and,
- Replace all traditional column chromatographies (e.g. Protein A affinity column chromatography, ion-exchange chromatography)
The continuous modular process flow is designed to:
- Terminally interface with traditional, semi-continuous viral inactivation/removal and ultrafiltration/diafiltration (UF/DF) processes to further prepare the product for fill-finish.
Provide a turn-key continuous, end-to-end bioprocess for the manufacturing and purification of monoclonal antibodies that maintains product throughput, recovery and yield on a tons/year basis, while significantly decreasing the following when compared to the traditional approaches of batch, single-use, or semi-continuous monoclonal antibody manufacturing:
The production facility footprint by at least an order of magnitude
The time required for facility buildout and validation
The costs associated with facility buildout
The capital equipment expenditure
Significantly decrease operating expenditures, overall bioprocess line downtime, and biological product loss when compared to traditional monoclonal antibody manufacturing approaches
Increase the overall purity of monoclonal antibodies
Replace centrifugation and depth filtration processes
Replace all traditional column chromatographies (e.g. Protein A affinity column chromatography, ion exchange chromatography, hydrophobic interaction chromatography)
Enable the utilization of smaller, more streamlined equipment (e.g., smaller bioreactor volumes and downstream bioprocess equipment), as the ability to operate continuously eliminates the need for the large process equipment required for the centrifugation, depth filtration, and column chromatography steps of traditional downstream bioprocessing, whose large footprint is dictated by large, batch bioreactor volumes and surface area constraints.