Manufacturing
Bavarian Nordic's commercial-scale
manufacturing facility in Kvistgaard, Denmark is designed for the
manufacture of poxvirus-based vaccines and has been dedicated for
the production of IMVAMUNE® smallpox vaccine, mostly for the
U.S. Strategic National Stockpile.
Over the past years, the Company has
succeeded in optimizing production efficiency significantly and
accordingly has turned smallpox vaccine production into a
profitable business. Further work is ongoing to improve the
manufacturing process and its productivity, thus seeking to further
improve the profitability of the current and future expected
contracts with the U.S. Government to manufacture and deliver
IMVAMUNE®.
To fully benefit from the in-house
expertise in poxvirus-based vaccine manufacturing as well as to
optimize the use of the Kvistgaard facility, Bavarian Nordic has
decided to transform the facility in into a multipurpose facility
to meet the Company's manufacturing requirements in the short,
medium and long-term.
Specifically, the facility will be
prepared for the future commercial production of PROSTVAC® and
it will take over production of clinical trial material for the
Company's preclinical development projects, which have previously
been produced at the Company's pilot production plant in Berlin,
Germany. As part of this consolidation, the Berlin facility
will close during 2013.
The transformation of the Kvistgaard
facility into a multipurpose manufacturing facility will allow
Bavarian Nordic to take a more flexible manufacturing approach and
reduce dependence upon subcontractors, thus providing the
company greater control of pre-launch manufacturing activities for
PROSTVAC®.
The facility already has the necessary
quality systems and other support functions in place. Furthermore,
it makes use of disposable technologies, which is a great advantage
in the planning and execution of different manufacturing
campaigns.
