The plant, dubbed the Novo Nordisk Foundation Cellerator, will be fully owned by the Novo Nordisk Foundation and will be located at the Technical University of Denmark (DTU) in Lyngby, which already has experience and infrastructure related to cell manufacturing. Construction of the plant is planned to start in 2024 and the plant is expected to be open in 2027.
The Cellerator will be geared towards manufacturing cell therapies that have passed preclinical development ready for early clinical trials. The plant would support developmental processes including manufacturing and product release, and would provide guidance regarding regulations. Cell types that it would produce include cells derived from embryonic stem cells, induced pluripotent stem cells and adult stem cells.
According to the company, the Cellerator would be the first centralized, large-scale production site for cell therapies in Denmark, with current facilities being limited to small-scale sites in hospitals.
“Cell therapies have the potential to take us from treating or managing the symptoms of chronic diseases to treating the disease itself, or even curing it with a one-off procedure,” said Thomas Carlsen, CEO of the Novo Nordisk Foundation Cellerator, in a public statement.
“We’ve seen major advances in the laboratory in recent years, but many promising cell therapy candidates face difficulties reaching clinical trials, partly because we can’t currently develop cell therapy products in large, consistent quantities here in Denmark. I’m thrilled to be heading an initiative that will change this and provide hope to people living with chronic diseases.”
Potential beneficiaries
One of the potential beneficiaries of the Cellerator is an international research consortium called reNEW. The initiative develops cell therapies and sees the facility as an opportunity to help its projects to move into clinical testing.
“Partnering with academic, clinical and biotech scientists in the field is key to succeeding with future curative therapies,” said Mads Krogsgaard Thomsen, CEO of the Novo Nordisk Foundation, in a public statement. “And we’re setting our sights even higher too. We believe the Novo Nordisk Foundation Cellerator can be a leading player in Europe and a model for similar facilities around the world, helping Denmark to punch above its weight in the search for cures to some of the world’s most serious chronic diseases.”
The big pharma company Novo Nordisk, which is partly owned by the Novo Nordisk Foundation’s Novo Holdings, is on its own mission to expand its manufacturing capacity as its weight loss treatment Wegovy booms in sales. For example, the company invested $2.29 billion in an expansion of existing active pharmaceutical ingredient (API) production facilities in Denmark earlier this year.
The latest cell therapy plant announcement comes as reports have surfaced of quality control concerns by the U.S. Food and Drug Administration (FDA) at Novo Nordisk’s API manufacturing plant in Clayton, North Carolina, U.S., last year. The FDA told Reuters that the agency currently has no information suggesting ongoing compliance issues that raise concerns about the quality of drug products manufactured at the site.