Novo bought the 180,000 square-foot plant from CMO Olympus Biotech in August. The facility will produce products for the treatment of hemophilia in the US, including the long-acting recombinant factor VIII, N8-GP for those with hemophilia A.
The additional employees will add to the 130 facility personnel currently employed at the site who have expertise in manufacturing and facility operations, engineering, development, quality assurance, quality control, validation, and operational excellence.
"We're pleased to be bringing this site back to life, and make it a part of Novo Nordisk's growing network of manufacturing sites," said Steen Weber Jensen, corporate VP, Novo Nordisk. "Our long-standing commitment to patients and families affected by hemophilia means we have to continuously improve how we supply our medicines, and this new site will give us new, vital capacity."
The site was set to close on the same day that Novo stepped in and bought it. Terms of the acquisition were not announced but Olympus said back in March that it was reducing the price of the plant to a “nominal value.”
According to Olympus, the plant houses two mammalian cell culture suites with fixed and single use platforms as well as an area dedicated to process development activity. Each suite offers independent cell culture equipment trains and dedicated areas for product recovery and purification. Downstream areas can support an array of column chromatography and filtration processes including affinity, ion exchange, hydrophobic interaction, gel filtration, ultrafiltration, and diafiltration. Clinical aseptic fill capacity was recently introduced at the site using barrier isolator technology.
"Novo Nordisk is making a long-term investment in the Upper Valley, and we're glad that New Hampshire is a part of the company's manufacturing division," added Peter Gariepy, vice president and site manager for the West Lebanon plant. "The community can look to Novo Nordisk to be a cornerstone for the foreseeable future."
Meanwhile, Novo Nordisk announced last week that it has been served with a subpoena by the office of the US Attorney for the District of Massachusetts requesting documents regarding potential manufacturing issues within certain production units located in Kalundborg, Denmark.
“Novo Nordisk is cooperating fully with the US Attorney in this investigation. At this time, Novo Nordisk cannot determine or predict the outcome of this matter or assess the consequences thereof. In addition, the company cannot predict how long the investigation will take or when it will be able to provide additional information,” the company said in a statement.