Initiation of large-scale manufacture is a very comprehensive and lengthy process. It requires that the production process is transferred from the pilot plant to a manufacturing facility and that the process can be scaled up 10, 100 or more times, so that a sufficient amount of the vaccine can be produced to supply market demand. In some situations, for example in the case of Bavarian Nordic’s smallpox vaccine, it can require the construction of an entirely new manufacturing facility. The design and construction of a vaccine manufacturing facility is subject to very strict regulatory controls, taking normally 2½-3 years to design, build and qualify a new vaccine manufacturing plant.
In 2002, Bavarian Nordic established a strategic collaboration agreement with IDT in Germany, for the development of a modern, effective industrial process for the manufacture of very large quantities of MVA-BN®. From 2002 and up until today, Bavarian Nordic has worked with IDT on the development, upscaling and industrialisation of the MVA-BN® production process.
In June 2005, the production process was successfully transferred from IDT to the Kvistgård site and testing of the full-scale MVA-BN® manufacturing process began. The Kvistgård site began test-production in September 2005. Activities to validate the plant and production process ran in parallel with the start of operations throughout the remainder of the year.
In September 2006, the company received manufacturing authorisation from the Danish Medicines Agency to produce MVA-BN® in accordance with full EU cGMP requirements.
