Novartis opens its largest gene therapy plant to support Zolgensma

The doors have opened at a facility in Longmont, Colorado nine months after Novartis acquired it to support its gene therapy business unit AveXis.

In April 2019, Novartis bought the Longmont facility from fellow Big Biopharma player AstraZeneca in efforts to grow out its gene therapy production network.

Nine months on and the Swiss Biopharma has confirmed the site is open and prepped to support its AveXis unit in the production of therapies including Zolgensma (onasemnogene abeparvovec-xioi1), which was approved by the US Food and Drug Administration (FDA) in May 2019.

Image: iStock/Derek Brumby

“The new site will be manufacturing gene therapies for rare genetic diseases, including our FDA-approved gene therapy for the treatment of spinal muscular atrophy (SMA) [Zolgensma],” Novartis spokesperson Anja von Treskow told this publication.

“The facility currently employs more than 300 talented scientists, engineers, analysts and manufacturing and operations personnel.”

While the plant is open, it will not become operational until early next year, she confirmed, but once licensed, it will not only add to sites in Illinois and North Carolina in providing Zolgensma manufacturing capacity but be the largest facility in AveXis’ manufacturing network.

Since acquiring AveXis for $8.7 billion (€7.8 billion) in May 2018, Novartis has invested heavily in its gene therapy production capabilities. Two further investments totaling $115 million have been made, aimed at establishing a gene therapy manufacturing center in Durham, North Carolina and expanding product development at a facility in San Diego, California.

“Colorado is the largest facility square footage wise in the manufacturing network while the site in North Carolina is currently being built out.”

Like the operational Libertyville, Illinois site, the Longmont plant is equipped with iCELLis bioreactor systems, supplied by bioprocess vendor Pall Corporation.

Long, Longmont history

The 700,000 square-foot facility set on 70 acres of land has had a host of Big Pharma owners.

Amgen once used the plant to produce drug substance for its blockbuster biologics Epogen (Epoetin) alfa and Aranesp (darbepoetin alfa).

Then in October 2016, AstraZeneca acquired the plant for an undisclosed fee. At the time the Anglo-Swiss firm said it planned to use the site – together with the nearby LakeCentre facility in Boulder, also bought from Amgen, albeit two years prior – to support its biomanufacturing ambitions.

However, early last year AstraZeneca restructured its operations in efforts to consolidate biomanufacturing at its Frederick, Maryland site and put both Colorado sites on the chopping block.