California, US-based BioMarin announced the approval this week, explaining it has been given the go-ahead to make the bulk substance N-acetylgalactosamine 6-sulfatase (GALNS) at the site in Shanbally.
The plant – which BioMarin acquired from Pfizer in 2011 - received equivalent approval from the European Medicines Agency (EMA) earlier this year. It is also licensed by the US Food and Drug Administration (FDA) to conduct QC and QA testing, packaging and labelling.
A spokeswoman told us the plant produced Vimizim prior to gaining approval explaining that "Now that the plant is approved, the material generated in 2015 is commercial product in the US."
She also said: "BioMarin is looking to hire approximately 50 people in a variety of full-time and temporary roles in Shanbally this year."
Vimizim was approved in the US and EU in 2014 to treat the rare congenital enzyme disorder Morquio A syndrome. A year's supply of the drug costs $380,000.
Production
At present commercial supplies of Vimizim are made at BioMarin’s facility in Novato, California. However, in 2015 the firm said it planned to start making it at the Irish site.
CEO Jean-Jacques Bienaimé said: "The Shanbally plant greatly expands our manufacturing capacity to accommodate our growing commercial portfolio and advancing clinical programs, as well as diversifies manufacturing risk associated by now having two licensed facilities.
He added that: “The flexible state-of-the-art facility gives us tremendous latitude for the types of products that can be produced at the facility."
The manufacturing process for Vimizim was detailed in the European Medicine Agency (EMA) assessment report.