The groundbreaking ceremony took place yesterday at the site in Kalundborg, Denmark where Novo Nordisk already has operations, with this new 7,500 m2 facility expected to be approved and fully operational by 2020.
"The primary product for this investment will be recombinant factor VII, the active ingredient in NovoSeven," Jan Hoff, Senior Vice President of Biopharmaceuticals, told Biopharma-Reporter.com.
NovoSeven is the Danish pharma company's recombinant treatment for patients with congenital haemophilia. The product contains the active substance eptacog alfa (activated) which is almost identical in action to the human protein factor VII, which helps enable the blood clotting process.
The Factor VII product was first approved by the US FDA in 1999 and is currently being produced from the site in Kalundborg, but the new facility will also support Novo Nordisk's haemostasis pipeline that includes N8-GP and N9-GP, glycoPEGylated long-acting recombinant coagulation factors VIII and IX respectively, both in Phase III trials.
"[The new plant] will be stainless steel in line with our current Factor VII production." Hoff said, and around 100 new production jobs will be created, adding to the current workforce of more than 2,800 people.
Hoff added the firm believes a new plant was preferential to using a contract manufacturer as "production of factor VII is a core competence for Novo Nordisk."
Novo Nordisk has been active about keeping the manufacturing of its nearly all its products in-house, with CEO Jesper Brandgaard telling investors in February the firm is set to invest up to DKK 5bn into its infrastructure.
Last year $100m was pumped into an insulin plant in Denmark, while the company acquired a biologics facility in New Hampshire from Olympus Biotech to support its haemophilia products. And just last month the company opened a new insulin formulation and filling plant in Kaluga, Russia.