J Pharm Pharmacogn Res 2(Suppl. 1): S115, 2014
Special supplement with the abstract book of LATINFARMA 2013
C 042: SIMULATION OF PLASMID RECOVERY PROCESS FOR A DNA VACCINE
Limonta M1, Lendero N2, Vidic U2, Zumalacárregui L.3
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, modeling of the downstream process was performed. A methodology based on process analysis tools, such as experimental design and modeling 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 it was modeling in SuperPro Designer.
The use of this Software as a computer tools is important in order to consider the economic impact of some process parameters such as recovery, purity and lifetime of matrices on the downstream process. This methodology was found very convenient to identify where cost reduction can be achieved at early stage of the development project before the final stage of clinical trials was reached. The use of CIM C4 HLD, a monolith based media, instead of traditional beads based media at laboratory scale gives the necessary information to design a new process which could be increase productivity and equipment requirements.