Ramboll has been commissioned to provide a turnkey service for a new cGMP/GMO 2 production facility.
Manufacture of novel vaccines based on Bavarian Nordic’s unique technology using chicken embryo fibroblasts will be manufactured in the new facility. The facility is designed to prevent genetically modified organisms classified as GMO 2 from escaping to the environment by the use of containment technologies.
The new facility will manufacture sterile biological products on campaign basis and is designed to provide low bio burden conditions during production through the establishment of grade D to A cleanroom conditions according to EU GMP. In the final stage of manufacture all open operations are performed under grade A and applied containment conditions in order to reduce possible contamination of product and to minimise risk of operator exposure.
Disinfection of the facility both during routine manufacture and also at the end of the production campaign and prior to product changeover is achieved by means of cleaning and fumigation using vapour phase hydrogen peroxide - the new building will be state of the art for flexible manufacture of novel vaccines.