MeiraGTx unveils Ireland's first site capable of commercial-stage gene therapy manufacturing

After operating under the radar for more than a year with a gene therapy production facility in Shannon, Ireland, MeiraGTx has emerged from the shadows with a formal unveiling.

In a ceremony that included Irish Prime Minister Micheál Martin, the New York City-based company took bows for its 150,000-square-foot plant, the first in the country capable of commercial-scale gene therapy manufacturing, MeiraGTx said.

Although MeiraGTx is a clinical-stage company, the biotech opted to build a site with end-to-end manufacturing capabilities. The company will provide its manufacturing services to potential collaborators, it said.

Why the delayed reveal? Ireland and its Industrial Development Agency wanted to announce the site last year when construction was complete, but COVID restrictions preventing gatherings forced the delay, MeiraGTx said through a company spokesman.

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The site includes three facilities. One is built to be flexible and scalable for clinical and commercial viral vector production. Another is for the manufacture of plasmid DNA, the critical starting material for gene therapy products. The last performs biochemical quality control testing.

MeiraGTx said bringing all aspects of production in-house will cut costs, reduce regulatory risks and help avoid bottlenecks that have become all too common in gene therapy production. The site will cut months or even years off the time to manufacture products, the company said.

The factory is ready to employ 100 in its current phase of operation, with the potential to gear up to 300, the company said.

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MeiraGTx has six programs in clinical development, including four in ocular indications. In 2019, the biotech partnered with Johnson & Johnson, which paid $100 million upfront to get a piece of the action in the biotech’s treatments for achromatopsia and retinitis pigmentosa.

The year before, J&J joined forces with MeiraGTx on its riboswitch technology, which enables innovative gene therapy treatments with expression that can be turned on and off by way of a small molecule.

The company also has a 29,000-square-foot manufacturing site in London, which has the capacity to supply the company’s clinical trials.