IMPROVED SEED TRAIN STRATEGY APPLIED TO PER.C6® CELLS FOR MANUFACTURING READINESS IN VACCINES PRODUCTION

摘要

The prevention of infectious diseases is a major goal for global healthcare and vaccines are still among the best preventive tools. The recent Ebola virus outbreak has challenged the vaccine industry to boost the speed to market and process development activities for new vaccines. To be able to cope with infectious disease outbreaks, our company developed an intensified cell and virus culture process using PER.C6® cells and AdVac~(™ ) platform. In our intensified process, perfusion bioreactors are used to increase Adeno vector titers while minimizing capital investments. To further increase readiness and flexibility for manufacturability, we improved the current process by substituting the classical cell culture seed train with an innovative concept called LVHD (Large volume high density) where the seed train can be generated from a single bag of cells at high density reducing significantly the time needed for the final cell culture. In the current study the LVHD expansion train in comparison to the classic roller bottle expansion was evaluated in regard to Cost of Goods, facility footprint and operational flexibility. Moreover, the Adeno vector drug substances obtained from the two processes were compared. Finally, the robustness and consistency of our LVHD seed train will be shown by using Monte Carlo simulation approach.