HIP-Vax® is a highly intensified production platform for viral vaccines. It enables fast and low-cost manufacturing.
Vaccines have a profound impact on global health, improving the quality of life by reducing the morbidity and mortality of viral infections. However, current costs of vaccine manufacturing often prevent the poorest segments of the world population from accessing these critical medicines. A significant contributor to these costs is the result of vaccine manufacturing in large and expensive facilities. To overcome this hurdle, we design highly intensified manufacturing processes for viral vaccines in all stages of development, branded as HIP-Vax. The production processes leverage massive process intensification to significantly change the face of vaccine manufacturing. It makes use of NevoLine™, an equipment component marketed and developed by Univercells. The HIP-Vax packages comprise complete protocols of the production and purification processes, optimized cell lines and virus seeds. It can be easily implemented by vaccine manufacturers to deliver large volumes of viral vaccines at very low cost.
The production process uses a novel bioreactor design (scale-X™ bioreactor) that delivers very high cell densities and virus yields per bioreactor volume up to 40-fold higher than traditional technologies. In addition, high efficiency purification membranes (Merck Millipore) and state-of-the-art process intensification expertise 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 traditional 1,200 L stirred-tank bioreactor can be delivered by a 60 L packed-bed bioreactor. The complete process of virus production, purification and inactivation can be performed in a footprint of 35 m2. Such miniaturization makes commercial manufacture possible at lab scale, significantly reducing cost of goods for the manufacture of these vaccines.
The first vaccine for which we developed a highly intensified production process is IPV. The IPV package comprises complete protocols of the production, purification and inactivation processes, optimized Vero cell lines and poliovirus seeds. Cost of goods modeling using current yields obtained at small scale indicate a fully loaded cost of goods at <USD$0.30 per trivalent dose of drug product, an approximate 5-fold reduction on current IPV prices. Moreover, the vaccine can be produced in a small footprint facility, costing approximately USD$30-40 million and capable of delivering 40 million trivalent doses per year. Performance of the manufacturing process in an isolator-based “micro-facility” (NevoLine™) will facilitate poliovirus containment Global Action Plan (GAPIII) certification.