MeiraGTx Unveils Gene Therapy Site in Ireland

MeiraGTx Holdings plc, a vertically integrated, clinical stage gene therapy company, officially introduced its good manufacturing practice (GMP) facility in Shannon, Ireland. The center, online since earlier this year and over 150,000 square feet in size, is the first commercial-scale gene therapy manufacturing site in the country, MeiraGTx notes. It is comprised of three facilities:

• One built to be flexible and scalable for viral vector production for clinical and commercial supply
• A facility to manufacture plasmid DNA (the starting material for producing gene therapy products)
• A quality control (QC) hub performing advanced biochemical quality control testing for the company’s clinical and commercial programs

The Shannon site allows MeiraGTx to accelerate the development and delivery of gene therapy treatments to patients facing a various genetic and non-hereditary disorders, ranging from inherited vision loss, salivary-gland conditions, and neurological diseases, such as Parkinson's, to potentially diabetes, obesity, and some cancers.

By building end-to-end gene therapy development, testing, and manufacturing capabilities in-house, MeiraGTx has put in place the infrastructure and technology required to avoid bottlenecks in clinical development, reduce regulatory risk, and provide products for patients, while lowering costs.

“MeiraGTx’s Shannon facility is unique, not only in Ireland but globally, as it streamlines gene therapy development, testing, and manufacturing capabilities together in-house,” notes Alexandria Forbes, PhD, president and CEO of MeiraGTx. “This significantly reduces the time to patients for advanced therapeutic products, with months or potentially years saved. Along with our other facilities in New York, London, and Amsterdam, the Shannon site will scale up and manufacture a broad range of gene therapies for people living with a variety of serious conditions.”