Technology and Innovation

End-to-end Manufacturing Ecosystem

Over the past decade, cell and gene therapies have revolutionized how serious diseases can be treated and potentially cured. Prior to gene-based therapies many of these diseases were effectively untreatable. The realization of these promising therapies has come through scientific advances in a range of disciplines including molecular biology, gene regulation, protein engineering and production methodologies. Manufacturing science and technologies are critical components in the development and clinical application of safe and effective genetic medicines for the patients who need them most.

Every step in the manufacturing process is essential to having a safe and effective GMP product:

MeiraGTx has brought all aspects of manufacturing, quality control, and process development in-house. With manufacturing as a fully integrated vertical component of the Company, our capabilities have allowed us to alleviate one of the most significant bottlenecks in the clinical development process as well as reduce regulatory risk and ensure the delivery of safe, potent, and effective products, all while decreasing our cost of goods.

MeiraGTx has comprehensive end-to end-manufacturing capabilities with a commercial ready platform process and GMP-licensed manufacturing and QC facilities in both the UK and Ireland, comprising the following:

• Two GMP-licensed, flexible and scalable gene therapy manufacturing facilities both fit for commercial production. in London, UK and in Shannon, Ireland.
• In-house GMP plasmid production facility (Shannon) under the same quality systems as the gene therapy production and QC facilities. Our in-house GMP plasmid is a starting material for clinical and commercial gene therapy production.
• In-house QC facility (Shannon) for full stability and release of manufactured gene therapies, with both a Commercial and Clinical GMP license from the Irish HPRA.
• MSAT facility (London) for the development of our proprietary platform process for gene therapy production, as well as development and validation of the QC assays required for gene therapy release and stability. Our MSAT team has built immense data sets supporting our platform process developed using multiple different capsids and vector genomes with both yield and full:empty capsid ratio at the top of the range published in the industry.

Combined, MeiraGTx’s facilities offer the flexibility and scalability to support the supply of innovative genetic medicine product candidates at all stages of the product development cycle, from pre-clinical stages through clinical trials and commercialization.

Our manufacturing sciences, manufacturing and quality team consists of more than 180 highly trained, multidisciplinary staff with backgrounds in a diverse array of manufacturing sciences, technologies, analytics and production. Our specialized team is working to expedite the delivery of genetic medicine products and is committed to ensuring MeiraGTx’s platform process continues to be at the forefront of this industry and is focused on quality and production efficiency to ensure we deliver the safest and most effective science to our patients.