In record time, Bavarian Nordic has established the world’s only dedicated facility for the industrial manufacture of MVA-based vaccines. The plant is unique, not only because it is the only plant of its kind built specifically for large-scale MVA vaccine production, but also because of its design, construction, and capacity.
State-of-the-art design The plant has been designed and constructed to fulfil the strictest European and US requirements for the production of sterile, live vaccines. In a number of areas the facility has been designed at a higher standard than required by authorities. In the growing market for vaccines, the facility is ready to adapt to potentially more restrictive requirements in the future.
In response to existing safety requirements, Bavarian Nordic’s entire production process takes place within a closed system. The facility has been constructed and approved to fulfil the legal requirements for the handling of live micro-organisms, including genetically modified vaccines. While the MVA-BN® smallpox vaccine is classified as a Bio Safety Level-1 (BSL-1) vaccine, the company introduced its own additional requirements in the design and construction resulting in a facility that complies with the more restrictive BSL-2 regulations.
Fill and finish of products Bavarian Nordic has decided to place the fill and final treatment of MVA-BN® vaccines with its strategic partner, IDT which operates a modern facility designated for filling, inspection, labelling and packaging of sterile vaccines.
Future production The Kvistgård facility has been designed so that other vaccines than IMVAMUNE® smallpox vaccine can be manufactured at the site. All of Bavarian Nordic’s current and future recombinant vaccines based on the MVA-BN® technology can readily be produced at the facility.
Furthermore, it is possible to manufacture a number of other vaccines at the facility, as well as to establish additional units that can operate with other technologies than those used today. While the company continues to investigate the production of other vaccines, in the near-term, only MVA-BN®-based vaccines will be manufactured at the Kvistgård facility.
