Bavarian Nordic established its own pilot plant in Berlin in 2003, to secure the necessary capacity for producing recombinant MVA-BN®-based vaccines for its clinical trials. The pilot plant is an independent biopharmaceutical unit equipped and manned to carry out the entire production process; from receiving the MVA-BN® virus from the company’s research laboratories, to the production of clinical batches for Phase II trials. The pilot plant has four clean rooms equipped with the most modern technology for the production of raw vaccines as well as for formulation, filling and freeze-drying of vaccines.
The Berlin facility fully implemented the MVA-BN® production technology in 2004. Early in 2005 the facility was 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 able to produce within its own manufacturing network, large quantities of clinical trial materials for its global development programmes, the first priority being the production of clinical materials for the HIV multi-centre programme.
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