The company has invested €38m ($42m) over four years to add an aseptic production facility.
The new facility will manufacture, package and label BioMarin therapies for global distribution. Alongside end-to-end manufacturing for the company’s commercial products, the site now has the capacity to produce additional clinical and commercial products (including gene therapies) as the company grows its pipeline.
Global supply network
BioMarin opened its first site in Ireland in 2012 with 12 people. The company now employs more than 500 people across two locations in Ireland: the Shanbally manufacturing site and Earlsfort Terrace in Dublin, which serves as BioMarin’s headquarters for Canada and Europe.
Shanbally is the company’s only manufacturing site outside of the US to boast a fully integrated manufacturing process, from bulk drug substance to drug product to final packaging. The site also represents one of a limited number of facilities in Ireland that have the capabilities for end-to-end commercial drug product manufacturing, according to IDA Ireland, the Irish agency tasked with attracting foreign investment.
Investments at the site have seen production levels increase by as much as 150% for some of the company’s products.
BioMarin is also investing more than €30m ($33m) expanding its packaging operations at Shanbally and will recruit more than 40 roles across its operations at the site over the coming years.
BioMarin says the investments are required to support rising demand for its therapies in Europe and worldwide.
“Our wholly-owned, end-to-end manufacturing sites, including Shanbally, are critical to BioMarin’s global supply capabilities,” said Greg Guyer, Ph.D., Chief Technical Officer and Executive Vice President, Technical Operations of BioMarin. “This expansion positions us as a leading manufacturing operation in Ireland and will help us maintain our industry-leading production and delivery capabilities for patients around the world.”
California-headquartered BioMarin has eight marketed treatments, including its first gene therapy Roctavian (valoctocogene roxaparvovec). The therapy was authorized by EU regulators in August last year; in the US, a decision from the FDA is expected by the end of June.