FDA gives nod to BioMarin’s Ireland bulk biologic manufacturing facility

The Ireland-based plant is the first international manufacturing facility for BioMarin.

The FDA approved manufacturing operations at BioMarin’s Cork, Ireland, bulk biologic manufacturing facility that will produce an ingredient of Vimizim used to treat Morquio syndrome.

The plant is the first international manufacturing facility for BioMarin, which bought the operations from Pfizer in 2011.

The company has said it plans to expand the facility from its current 200,000 square feet situated on 20 acres to include an expanded warehouse, utilities and new office space, the Irish Examiner reported.

The site received EMA approval earlier this year.

"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,” said Jean-Jacques Bienaimé, BioMarin’s chairman and CEO. “In addition, it provides flexibility and capacity for our largest and fastest growing commercial product, Vimizim, to meet projected demand for the foreseeable future. The flexible state-of-the-art facility gives us tremendous latitude for the types of products that can be produced at the facility."

The company said with the regulatory agency approval it will shift the focus of its manufacturing of Vimizim to Ireland.