iCAP Project targets world-first continuous pDNA production
Recombinant proteins and genetics specialist CDMO enGenes Biotech has embarked on a potentially transformational project to create a platform for continuous automated production of plasmid DNA (pDNA).
The iCAP Project (Integrated Continuous and Automated Platform for Plasmid Production) is partly consequent from the success of the ECOnti collaboration for continuous protein production that united enGenes with development partners novasign® and Qubicon® AG to pioneer continuous production processes for proteins.
Transformational project
The goal of iCAP is to establish a scalable, intelligent pilot system that can deliver consistent, cost-effective, and eco-friendly pDNA for cell and gene therapy, viral vectors, and mRNA vaccines. If successful, it will create the first single fully continuous low-cost pDNA production center to be found anywhere in the world.
This would be transformational for the pharma and biotech industries that currently face challenges with current pDNA production methods that are inefficient and costly, relying on discontinuous batch and fed-batch processes. Cost-effective and efficient continuous production of pDNA would enable a significant reduction in the manufacturing costs of the novel drugs required for medical progress.
Advanced technologies
iCAP will use genetically stabilized Escherichiacoli (E. coli) bacterial strains, combined with enGenes proprietary technologies such as -excess™ as an efficient and robust platform for the manufacturing of high-quality pDNA with upstream and downstream processes optimized to enable significant yield improvements, and exchange™, for enhanced production of plasmids without antibiotic resistance markers, enhancing safety, efficiency, and regulatory compliance.
Dr. Jürgen Mairhofer, CEO of enGenes, commented: “With iCAP we are looking to perfect a stable and efficient continuous process that ensures consistent high-quality pDNA production that can significantly reduce costs, and improve sustainability by minimizing waste and resource consumption.”
“In doing so, we can also create a scalable, automated production platform that can be applied to other biotechnological processes,” Dr. Mairhofer noted.
Combined strengths
The iCAP project will again unite enGenes’ innovative science-driven innovation in continuous plasmid manufacturing with novasign® expertise in development and optimization of bioprocesses using advanced machine learning solutions such as hybrid modeling tools and digital twins and Qubicon® AG’s digital platform for advanced real-time monitoring and flexible process control.
The whole iCAP project has benefited from additional funding provided by the Vienna Business Agency Wiener Wirtschaftsargentur.