The pharmaceutical firm has built the site with three facilities, one built to be flexible and scalable for viral vector production for clinical and commercial supply, a facility to manufacture plasmid DNA, and a Quality Control (QC) hub
US biotech company MeiraGTx has unveiled its GMP manufacturing facility in Shannon, Ireland, with Irish Government head Micheál Martin in attendance.
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 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 programme.
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
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.
Micheál Martin said: “Today is an important day for MeiraGTx in Ireland, as we mark the formal unveiling of their state-of-the-art manufacturing facility. Great strides are being made in the area of gene therapy and I’ve no doubt that these new facilities will allow MeiraGTx to remain at the forefront of that development.”
Alastair Leighton, PhD, Senior VP 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.