FDA approves BioMarin’s manufacturing facility in Ireland

US company BioMarin Pharmaceutical Inc has announced that The Food and Drug Administration (FDA) has approved a bulk biologics manufacturing plant, located in Shanbally, Cork, Ireland for production of the formulated bulk substance (N-acetylgalactosamine 6-sulfatase (GALNS) used in the production of Vimizim® (elosulfase alfa) for the treatment of Mucopolysaccharidosis IVA (MPS IVA, also known as Morquio A Syndrome).
The plant, which was acquired from Pfizer in 2011, is built on twenty acres occupying 200,000 square feet of floor space. The plant was certified by the Health Products Regulatory Authorities (HPRA) on behalf of the European Medicines Agency (EMA) in Q1 2017. The plant has been licensed by FDA for a range of activities including bulk production, QC testing, QA release, final product secondary packaging (labeling and packaging) and distribution.
In addition, BioMarin is completing construction on a number of expansion projects at the facility to allow for continued growth at the site and to maximize the flexibility and operational capacity of this important asset. These projects included an expanded warehouse, new office space and improved and expanded utilities. During this construction, BioMarin has engaged the services of local workers to complete these projects.
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.”
Martin Shanahan Chief Executive Officer of IDA Ireland, said: “BioMarin has made a substantial commitment to manufacturing in Ireland since acquiring their Cork facility in 2011. BioMarin’s development of treatment options for ultra-orphan rare diseases represents the type of innovative science that IDA wishes to attract to Ireland. The south west region offers local workers an excellent quality life and the local economy has in turn benefitted significantly from the company’s investment. Today Ireland continues to be viewed as the ideal location for biopharmaceutical companies looking to grow their operations, with a highly educated workforce and an excellent track record. I am confident that BioMarin will continue to thrive and grow in Ireland over the coming years.”
Robert Baffi, Executive Vice President of Technical Operations, stated: “The first cycle approval of this facility by FDA is a testament to our capabilities and thorough understanding of facility design and regulatory requirements involved in the tech transfer and production of one product at two different manufacturing facilities. Our experience in the design, construction and approval of multi-product manufacturing plants is a hallmark of BioMarin’s success and technical prowess. As we continue to grow, we are looking to hire the best and brightest in a variety of disciplines in Shanbally.”
BioMarin is a global biotechnology company that develops and commercializes innovative therapies for patients with serious and life-threatening rare and ultra-rare genetic diseases. The Company’s portfolio consists of six commercialized products and multiple clinical and pre-clinical product candidates.