FDA approves BioMarin’s Irish facility
pharmafile | June 13, 2017 | News story | Manufacturing and Production | BioMarin, Ireland, cork, vimizin
The FDA has approved BioMarin’s bulk biologic manufacturing plant, based in Cork, Ireland. The facility will manufacture an ingredient of Vimizin, BioMarin’s synthetic enzyme for those suffering from Morquio syndrome.
BioMarin’s facility is the first facility that the company has launched internationally. It had purchased the plant from Pfizer in 2011 and it is now licensed for bulk production of ingredients, QC testing, labelling, packaging and distribution.
BioMarin are also continuing to expand the facility beyond its current size, which currently stands at 200,000 sq ft. The plant stands on 20 acres of land and therefore there is plenty of space for the planned warehouse expansion, alongside new office spaces.
Jean-Jacques Bienaimé, Chairman and Chief Executive Officer of BioMarin stated, “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. 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 manufacturing plant was given approval by the EMA is the early part of this year. The licensing of the facility means that the company will shift the focus of its manufacturing of Vimizin to Ireland.
It’s another example of the confidence companies have in having a manufacturing base in Ireland, which has attracted a wealth of biopharmaceutical companies over the last few years.
Ben Hargreaves
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