Operational since earlier this year and stretching over 150,000 sq. ft (13935.4 sq. m), it is the first commercial-scale gene therapy manufacturing site in Ireland.
The newly developed complex comprises three facilities, one built to be flexible and scalable for viral vector production for clinical and commercial supply, a unit to manufacture the starting material for gene therapy, plasmid DNA, and, finally, a quality control (QC) hub designed to perform advanced biochemical quality control testing for MeiraGTx clinical and commercial programs.
MeiraGTx said the Shannon site allows it 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.
Accelerated development time
The site is intended to significantly reduce the time to patients for advanced therapeutic products.
By building end-to-end gene therapy development, testing, and manufacturing capabilities in-house, MeiraGTx said it 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.
Addressing supply chain bottlenecks
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 COVID-19 pandemic exposed the shortcomings in the supply chain, and it created shortages and delays across the entire gene therapy industry, slowing preclinical research, clinical trials, and the production of life-saving treatments, noted Alastair Leighton, senior vice president of manufacturing and supply chain at MeiraGTx.
“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,” he added.
The gene therapy developer chose Shannon due to its proximity to a number of world-class bioscience institutions, as well as partner companies in the healthcare sector.
Martin Shanahan, CEO of IDA Ireland, said that 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.
The Irish site will employ 100 people in its current phase, with MeiraGTx adding there is the potential for that to increase to over 300.