Simulation for the recovery of plasmid for a DNA vaccine

• We model the pIDKE2 downstream process using a computer aided software.
• We evaluate the impact of pDNA's recovery and productivity for the intermediate steps on unit production cost using the SuperPro-Designer.
• The uses of monolithic matrix for pIDKE2 purification reduces the unit production cost 39% less than the process described before.
• The uses of SuperPro-Designer is very convenient to identify where cost reduction can be achieved at early stage of the development project.

The pIDKE2 plasmid is the main component of the CIGB's candidate vaccine against Hepatitis C virus (HVC), which is being used in HCV chronically-infected individuals during clinical trials phase 1 and 2. The designed downstream process of pIDKE2 plasmid produces up to 179 g/year. In order to conduct further improvements, modelling of the downstream process was performed. A methodology based on process analysis tools, such as experimental design and modelling was established to identify factors with the highest influence on production cost and the amount of annual plasmid. Taking into account that the pIDKE2 downstream process designed is in its initial stages of development, CIM technology was evaluated as a new manufacturing process on lab scale. Purity and recovery of CIM technology was better than porous particle matrix, thus SuperPro Designer was used in order to simulate the purification process. Cost efficiency optimization of the pIDKE2 downstream process was done with the simulation model.