BioMarin Invests €60 Million to Expand Manufacturing Facility in Ireland

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On Dec. 9, 2024, BioMarin Pharmaceutical announced a €60 million (US$63 million) investment to expand its state-of-the-art facility in Shanbally, Co. Cork., Ireland. With the investment, the company will add a new, four-story laboratory that will enable it to increase production capacity for currently approved drugs and allow for future growth, according to a press release (1).

The expansion adds to BioMarin’s footprint in Ireland. In addition to the manufacturing site in Shanbally, the company also operates a commercial office in Dublin and employs more than 500 people in Ireland. The company initially acquired the Shanbally manufacturing facility, which was at the time a bulk biologics manufacturing plant, from Pfizer in 2011 for US$48.5 million (2).

“This investment in our Cork facility reflects our ongoing commitment to enhancing our industry-leading global manufacturing capabilities and supporting the growth of our innovative medicines for our people living with rare conditions around the world,” said Evelyn Marchany Garcia, senior vice-president, chief quality officer, BioMarin Pharmaceutical, in the press release (1). “The Shanbally facility plays a crucial role in our global network, and this expansion emphasizes our confidence in Ireland’s skilled workforce and the strategic importance of this site to BioMarin’s long-term success."

The Shanbally facility represents BioMarin’s only manufacturing site outside of the United States. The facility’s capabilities include end-to-end manufacturing, producing therapeutics from bulk drug substance to drug product to final packaging. This €60 million (US$63 million) investment marks the second major significant expansion of the site. In 2023, BioMarin opened an aseptic production facility in Shanbally, which was a four-year build that enabled increased production of commercial and clinical products. The company invested €38 million (US$40 million) over four years to build the aseptic production facility (3).

“As a global leader in the biopharmaceutical sector, BioMarin’s ongoing investment in Ireland is a welcome endorsement of the country’s position globally as a location of choice for biopharmaceuticals and a trailblazer in advancing healthcare solutions. By opening this new quality control and process development laboratory, BioMarin will create new opportunities for collaboration, talent development and growth, ensuring that the life sciences sector in Ireland continues to make an impact on patients’ lives worldwide,” said Michael Lohan, CEO, IDA Ireland, in the press release.

“Expanding our laboratories allows us to deliver our medicines more efficiently and at greater scale for people living with genetic conditions. This latest investment reinforces our commitment to advancing treatment options and supporting patients across the world,” added Conor Delaney, site lead and vice-president of Shanbally Manufacturing Operations, BioMarin Pharmaceutical, in the release.

BioMarin has eight marketed therapeutics (4), including its first gene therapy, valoctocogene roxaparvovec, which was approved in Europe by the European Commission in August 2022 (5) and in the US by FDA in June 2023 (6).

References

1. IDA Ireland. BioMarin Announces Significant Investment and Expansion of Cork Facility. Press Release. Dec. 9, 2024.
2. BioMarin Pharmaceutical. BioMarin Agrees to Acquire Biologics Manufacturing Plant in Ireland from Pfizer. Press Release. June 23, 2011.
3. IDA Ireland. BioMarin Opens €38m Expansion of its Cork Manufacturing Site. Press Release. April 24, 2023.
4. BioMarin Pharmaceutical. Products. biomarin.com/products-and-pipeline/products/ (accessed Dec. 11, 2024).
5. BioMarin Pharmaceutical. First Gene Therapy for Adults with Severe Hemophilia A, BioMarin's ROCTAVIAN™ (valoctocogene roxaparvovec), Approved by European Commission (EC). Press Release. Aug. 24, 2022.
6. FDA. 2023 Approval Letter – ROCTAVIAN. June 30, 2023.