Industrial Manufacturing
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.
