Vaccines have a profound impact on global health, preventing illness, death and improving the quality of life. However, current costs of vaccine manufacturing often prevent the poorest segments of the world’s population from accessing these critical medicines. A significant part of these costs come from the need for typically large and expensive manufacturing facilities. To overcome this hurdle, we developed a highly intensified production process for inactive polio vaccine (IPV), called HIP-IPVTM. It enables fast and low-cost manufacturing for all in need. It can be easily implemented by vaccine manufacturers to deliver large volumes of IPV at very low cost. The production process leverages massive process intensification to polio vaccine manufacturing. It makes use of an equipment component, called NevoLine™, developed and marketed by Univercells. The HIP-IPVTM package encompasses complete protocols of the production, purification and inactivation processes, optimized Vero cell lines and virus seeds.
The production process uses a novel bioreactor design (scale-XTM bioreactor) that delivers very high cell densities and virus yields up to 40-fold higher than traditional technologies. In addition, high efficiency purification membranes and state-of-the-art process intensification know-how that can increase process output by a factor of up to 80-fold. This process intensification allows miniaturization of the manufacturing facility to such an extent that the output of a 1,200 L bioreactor can be delivered by a 60 L bioreactor in a footprint of 35 m2. Such miniaturization makes commercial manufacture possible at lab scale, massively reducing costs for manufacturing these vaccines. The use of an isolator-based “micro-facility” will facilitate Global Action Plan (GAPIII) containment certification.
CoGs modelling using current yields obtained at small scale indicate a fully loaded CoGs of <$0.30 per trivalent dose of drug product, an approximate 5-fold reduction over current IPV prices. Moreover, the vaccine can be produced in a small footprint NevoLine, costing approximately $30-40M and capable of delivering 40M trivalent doses per year. Performance of the manufacturing process in isolators allows this NevoLine platform for IPV to be fully GAPIII compliant.