BioMarin building $50m Irish fill/finish plant for orphan enzymes

The drug product plant in County Cork will support the fill and finish of BioMarin’s rare disease drugs Vimizim (elsulfase alfa) and Brineura (cerliponase alfa).

The filling facility at BioMarin’s site in Shanbally, County Cork represents an investment of €43 million ($50 million) and will create 51 additional jobs.

“We regularly evaluate our manufacturing capabilities and which capabilities we do ourselves and which make sense to outsource,” BioMarin spokesperson Debra Charlesworth told BioProcess Insider.

The facility is is Shanbally, County Cork. Image: iStock/Tuomas_Lehtinen

“Based on our current business needs and the growth of the company, we determined that adding a fill/finish capability to our site in Shanbally addressed our needs in an efficient manner.”

“The overall project will allow the company to maximize the flexibility of the site with the expansion of the operational manufacturing capacity.”

The site houses the drug substance plants for BioMarin’s orphan drugs Vimizim (elsulfase alfa) for MPS IVA or Morquio A and Brineura (cerliponase alfa) for CLN2 disease, a form of Batten disease and Palynziq for the treatment of PKU.

In 2017, Vimizim net product revenues stood at $413 million, up 17% on the year prior. Brineura clocked in $8.6 million, but only received approval in April 2017.

Charlesworth did not divulge the capacity for the new facility but told us “the BioMarin site was licensed for commercial drug substance supply by the US FDA in May 2017 and 14 million units of product were packed and labelled at Shanbally in 2016.”

The expansion was welcomed by IDA Ireland, the agency responsible for attracting inward foreign direct investment into the country.

“The Shanbally operation is ideally positioned to accommodate this latest expansion due to the existing skill base and the proven track record of success in Cork over the past seven years,” said IDA executive director Mary Buckley. “Today’s high value investment in Cork further consolidates Ireland’s position globally as a location of choice for biopharmaceuticals.”