Aside from being established in only eleven months, Bavarian Nordic (www.bavarian-nordic.com) views its new vaccine facility as unique because its design and technology combine the opposing requirements for aseptic production and biosafety regulations. The cGMP and biocontainment facility produces 40 million doses or more a year of smallpox vaccine with novel solutions to some of the problems associated with genetic engineering production, according to the company.
Bavarian Nordic previously had limited production facilities but when it bid on a U.S. government contract to supply millions of doses of its third-generation Imvamune smallpox vaccine, quickly increasing manufacturing capacity became necessary. Bavarian Nordic will now invest $45 million to establish its own 9,000-m2 vaccine manufacturing facility in Kvistgaard, north of Copenhagen.
The engineering company, NNE (www.nne.biz) was enlisted to assist in site-selection, feasibility studies, and a conceptual design for the facility. NNE supplied the experience necessary to design genetic engineering production facilities and manage building, installation, and commissioning.
"The speed of the fast-track project was essential to our company. We are participating in the U.S. government's Department of Health and Services' program to develop a safe smallpox vaccine based on the modified vaccinia ankara (MVA) virus. A fully operational vaccine facility improves our position in the competition," says Karin Wassard, production director at Bavarian Nordic.
"Upon completion of the basic design, the companies quickly decided to decouple the construction of the production facility from the detailed process-equipment design to optimize the time schedule and increase flexibility," adds Mette Bregendahl, engineering manager at NNE.
The cooperation between the two companies extended to the joint selection of suppliers and equipment. NNE prepared the detailed design and managed the construction of the facility, as well as the project management.
Bavarian Nordic concentrated on process development, contact with U.S. stakeholders, organizational development, final decisions on the major aspects of the project, and equipment. Bavarian Nordic staff also worked with NNE to test the critical process equipment.
The 11-month project, from detailed design to handover (which normally takes 24-32 months), is especially noteworthy considering the size and classification of the cleanrooms, as well as the level of complexity in the parallel phases of the construction project, points out Wassard.