As the demand for plasmid DNA (pDNA) based gene therapy and vaccines increases, large-scale, cost-effective, and reproducible pDNA production is required. The key to success is a real-time in-process control method that ensures a high percentage of supercoiled pDNA in the final product. CIMac™ pDNA Analytical Column allows the monitoring of degradation products (open circular and linear pDNA), the removal of impurities (RNA), and ensures that each production step yields the amount of supercoiled pDNA anticipated.
This application note is an example of a pDNA purification process based on our CIM® HIP² Plasmid Process Pack™ with in-process control steps. The final product composition is confirmed by Agarose Gel Electrophoresis. The complete separation of all three pDNA conformations from a test solution within 10 minutes on the CIMac™ pDNA Analytical Column shows the versatility of the column.