Manufacturing is a key competence of any successful vaccine company. Vaccine companies must be able to produce sufficient product in a consistent and high-quality manner, to meet customer needs, and to adhere to regulatory requirements – all of which can be challenging. The Novavax manufacturing approach using insect cell culture and recombinant baculovirus is quite different from the traditional vaccine manufacturing approach and has many advantages. Our influenza vaccine manufacturing process uses recombinant protein nanoparticles, which do not require a pathogenic organism and which is high-yielding relative to both egg-based and mammalian cell-culture based manufacturing approaches. We are able to utilize single-use manufacturing systems, which eliminates the very high up-front costs of facilities and infrastructure. The need to clean/sterilize equipment between batches is also eliminated as product-contact surfaces are intended for a single-use and are then disposable. We also avoid the complex, automated facilities required to perform these tasks in traditional facilities, as well as the lengthy commissioning and validation of those processes. The result is a facility that can be built for a fraction of the cost (of egg-based facilities) in significantly less time.
The unique economics of the Novavax manufacturing process in single-use bioreactor systems also eliminates the need for large central facilities to drive low cost of goods. Instead, we can build smaller, more economical facilities to distribute influenza vaccine to regions that need a local supply. In the event of a pandemic influenza outbreak, this is particularly important as vaccine access is expected to be limited and countries may have a desire to be self-sufficient within their border, rather than depending on foreign suppliers and importation issues during a pandemic event.