Manufacturing & Supply Chain

MeiraGTx Holdings Plc, a vertically integrated, clinical stage gene therapy company, has formally unveiled its GMP manufacturing facility in Shannon. The facility, online since earlier this year and stretching over 150,000 square feet, is the first commercial-scale gene therapy manufacturing site in Ireland.

The facility is unique in its scale and integrated capabilities. The site contains three facilities, one built to be flexible and scalable for viral vector production for clinical and commercial supply, in addition, a facility to manufacture plasmid DNA – the critical starting material for producing gene therapy products – and thirdly, a Quality Control (QC) hub performing advanced biochemical quality control testing for MeiraGTx clinical and commercial programmes.

The formal unveiling marks a critical step in MeiraGTx’s mission to develop and deliver potentially curative treatments for patients living with serious diseases. The Shannon site allows MeiraGTx to accelerate the development and delivery of gene therapy treatments to patients facing a wide range of both 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 ensure the highest quality products for patients – all while lowering costs. The facility will also allow MeiraGTx the ability to provide manufacturing services to potential collaborators, helping to lessen the impact of industry-wide shortages of vital elements such as plasmid DNA and quality control services.

The facility, which is set to employ 100 people in its current phase, with the potential for that to increase to over 300, has been sited in Shannon due to its proximity to a number of world-class bioscience institutions, as well as partner companies in the healthcare sector. MeiraGTx is proud to have collaborated with The University of Limerick and the National Institute for Bioprocessing Research and Training (NIBRT) on skills and capability development and looks forward to building ever-closer relationships with other leading institutions across Ireland.

Zandy Forbes (pictured), President and Chief Executive Officer of MeiraGTx, said: “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. 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.”

Alastair Leighton, Senior Vice President of Manufacturing and Supply Chain at MeiraGTx, said: “The COVID-19 pandemic has placed a strain on the global gene therapy industry to manufacture critical components, as well as exposed the shortcomings in the supply chain. While vaccines are not gene therapies, they share many of the same manufacturing processes and resources. The Shannon facility has been designed to address these challenges in order to provide access to transformative potential medicines to patients as well as be ready for significant future expansion.”

CEO of IDA Ireland Martin Shanahan said: “In 2020, MeiraGTx announced its intention to locate this globally unique GMP manufacturing facility in Shannon. So, it’s terrific that two years later we can celebrate this official unveiling. IDA Ireland remains committed to winning jobs and investments across the country and MeiraGTx’s decision to locate in the Mid-West demonstrates the region’s reputation as a key location for the next generation of biopharmaceutical manufacturers.”