Bavarian Nordic A/S’ German Manufacturing Facility Approved by Legal Authority
Bavarian Nordic A/S announced today that its production facility in Berlin, Germany has been granted Manufacturing Authorisation by the Berlin Office for Occupational Safety, Protection of Health and Technical Safety (Landesamt für Arbeitsschutz, Gesundheitsschutz, und technische Sicherheit Berlin - LAGetSi).
Bavarian Nordic is now ready to produce within its own manufacturing network large quantities of clinical trial materials for the company’s global development programmes, the first priority of which being the production of clinical materials for the HIV/AIDS multi-centre programme.
Bavarian Nordic will use the same production method for the manufacture of clinical trial materials as in the manufacture of commercial quantities of the company’s MVA smallpox vaccine, IMVAMUNE™. With the new facility on-line, the company expects to initiate several new clinical trials this year, including 3 Phase ll trials in 2005 that will result in the vaccination of more than 2000 persons with IMVAMUNE™ by the end of the year.
Activities to prepare for the manufacture of IMVAMUNE™ at the Kvistgård site in Denmark is progressing as planned, with commercial production expected to begin in the summer of 2005.
