Under the HIP-Vax® brand, we market our process development services and know-how which enables fast and low-cost vaccine manufacturing using bioprocess intensification technologies.
Vaccines have a profound impact on global health, improving the quality of life by reducing the morbidity and mortality caused by infections. However, current costs of manufacturing often prevent part of the world population access to these critical medicines. A significant share of the manufacturing costs can be attributed to the need for large and expensive facilities. To reduce this part of the costs, we develop highly intensified manufacturing processes, branded as HIP-Vax. The production processes leverage massive process intensification to significantly change the face of vaccine manufacturing. We offer complete solution containing protocols of the intensified production and purification processes, including optimized cell lines and virus seeds. The processes are designed to allow smooth implementation by vaccine manufacturers in order for them to deliver large volumes of viral vaccines at very low cost.
The production process uses a novel bioreactor design (scale-X™ or iCELLis®) that delivers very high cell densities and virus yields per bioreactor volume, i.e. 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 significant miniaturization of the manufacturing facility. Such miniaturization makes commercial manufacture possible at lab scale, thereby significantly reducing the cost of goods for the manufacture of vaccines.
Whereas we offer our research and development services for any customer-specific vaccine, we also have HIP-Vax processes in place and available for licensing. Please contact us for more information.
The first vaccine for which we developed a highly intensified production process is IPV. The IPV package covers protocols for the production, purification and inactivation processes, including culture and handling of our optimized Vero cell lines and poliovirus seeds. Cost of goods modeling using yield data obtained in our R&D environment indicates 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.