A once-troubled sterile injectables plant that Xellia Pharmaceuticals spent nearly half a decade revamping is officially back in business.
The company on Tuesday said its Cleveland factory is commercially operational and has released the first anti-infectives made there for distribution to U.S. hospitals. Specifically, vials of lyophilized vancomycin—an antibiotic used to fight infection in the intestines—are the first products to be circulated from the site, which is Xellia’s sole production facility in the U.S., the company said over email.
Boehringer Ingelheim originally owned the facility but had to shutter it in 2013 after sterility lapses prompted dozens of drug recalls. After Xellia purchased the site in 2015, the factory had to be "extensively rebuilt" to the tune of $200 million, a spokesperson said.
Aside from manufacturing its own products there, Xellia is working with partners to chip in on contract manufacturing work for other lyophilized—or freeze-dried—vials, the company told Fierce Pharma.
Further, the company is also getting ready to ramp up a new aseptic bag manufacturing line. Countless medical supplies have fallen into shortage during the COVID-19 pandemic, from protective gear like masks and gloves to ventilators and IV bags. Similarly, materials used to make meds and vaccines, such as viral vectors and plastic bioreactor bags, have also been hard to come by.
In Xellia’s case, the company has been gearing up for the aseptic fill-finish of premix bags, or ready-to-use IV bags. Its manufacturing lines will be used to make “a range of products that require aseptic fill capabilities,” including Vanco Ready, a pre-mixed vancomycin injection in a ready-to-use bag, the company said in its email.
Xellia plans to produce more products at the Cleveland site over time, the company said.
The FDA gave Xellia the all-clear to start manufacturing at the site last March, but until now, no commercial products have been released.
The company has invested more than $200 million to “maximize” capacity for production, packaging, labeling and distribution of sterile injectables, Xellia said. The company has enlisted some 300 employees to staff the Cleveland site.
Apart from its Cleveland plant, Xellia operates production sites in Denmark, Hungary and China. Xellia is owned by Novo Holdings, which also owns Danish pharma major Novo Nordisk.
The company picked up the once-troubled site on its quest “to provide US hospitals and patients with critical care products made locally,” Carl-Åke Carlsson, CEO and president of Xellia, said in a statement. To that end, the company partnered with Civica Rx back in 2019 to produce antibiotics for the States, including vancomycin and daptomycin.
It’s unclear if the commercial start in Cleveland is linked to Xellia’s Civica Rx collaboration. The company told Fierce Pharma it can’t comment on specific customers.
Generics nonprofit Civica Rx formed in 2018 to help U.S. hospitals fend off drug shortages and price hikes. Since its debut, Civica has drawn big partners like Thermo Fisher and Novartis to its cause, plus the once-obscure Phlow, which last year snagged a $354 million federal contract to manufacture COVID-19-related meds, among other drugs.
As for the Cleveland facility itself, Germany’s Boehringer Ingelheim closed the plant and laid off more than 1,000 workers there after a federal consent decree made the prospect of revamping the plant too pricey.