In addition to commencing commercial supply, the facility is also preparing ramp-up of its recently installed aseptic bag manufacturing line
Xellia Pharmaceuticals, a manufacturer of anti-infective treatments, has announced its manufacturing site in Cleveland, Ohio is now commercially operational. The first anti-infectives manufactured at the site are to be distributed for use by US hospitals.
The anti-infective is the first drug product to be manufactured at the Cleveland site since it was bought by the company in 2015 and extensively rebuilt. The facility is now commercially active after operations commenced following the passing of a cGMP inspection by the FDA in 2020.
Carl-Åke Carlsson, CEO and President, Xellia Pharmaceuticals, said: “The release of the first commercial product manufactured at our Cleveland facility is a significant milestone for Xellia. We acquired the site to fulfil an ambition to provide US hospitals and patients with critical care products made locally. We are proud to be producing high quality, key anti-infectives and we look forward to working with more partners who are aligned with Xellia’s purpose to save patient lives.”
In addition to commencing commercial supply, the facility is also preparing ramp-up of its recently installed aseptic bag manufacturing line.
Patrick Brunner, VP, Manufacturing Operations North America added: “Xellia Cleveland is now commercially operational thanks to the hard work of our US team and employees across Xellia. Now that the site is in full working order, we will continue to ramp up our US operations to strengthen our market presence in anti-infective production and help provide the security of supply of vital drug products needed by US hospitals and patients.”
The company has established a workforce of more than 300 employees at the Cleveland site from the local area in addition to graduates from institutions such as the Ohio State University. Continuous expansion at the site is in line with the company’s long-term strategy, while also providing future employment opportunities within the Bedford community.
The site operates alongside the company’s other manufacturing plants in Copenhagen, Denmark; Budapest, Hungary; and Taizhou, China, as part of its vertical integration strategy.