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Bavarian Nordic announced today that its Quality Control laboratory at the Kvistgård site has been granted authorisation by the Danish Medicines Agency (Lægemiddelstyrelsen) to perform its own analyses and release on production batches of IMVAMUNE™ smallpox vaccine and MVA-BN® products for the use in the company’s clinical development programmes, and to release these products for eventual sale or for use in clinical trials.
All production equipment for operating at the manufacturing facility has been installed, and validation of the operational technical installations and ventilation systems has been started.
The company also reported that all other activities to prepare for the commercial manufacture at the Kvistgård site are proceeding as planned, and Bavarian Nordic still expects to produce 60 million doses of IMVAMUNE™ smallpox vaccine per year as per September 2005.
Copenhagen, 7 April 2005
Asger Aamund, Chairman of the Board
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