MeiraGTx Holdings plc, a vertically integrated, clinical-stage gene therapy company, has confirmed plans for a multi-million euro expansion in its Shannon facility.
The company has selected Shannon as the site of its second current good manufacturing practices, or cGMP viral vector manufacturing facility and cGMP plasmid production facility. These facilities will be designed for the manufacture of commercial-grade gene therapies in a fully integrated manner supported by MeiraGTx’s global quality assurance organisation.
MeiraGTx expects the Irish facilities, to provide additional flexibility as well as further large-scale capacity for clinical and commercial supply of its gene therapy product candidates from pre-clinical stages through clinical trials and potential commercialisation. This project is supported by the Irish Government through IDA Ireland.
The plasmid production facility is expected to be operational by year-end 2020, while the viral vector manufacturing facility is expected to be operational by year-end 2021.
The facility at Shannon Freezone Business Park, Co. Clare comprising 8,300m2 in two separate buildings will be designed to meet global regulatory requirements, including the cGMP required by the U.S. Food and Drug Administration (FDA). The unit at Shannon will be used for the manufacture of MeiraGTx viral vectors for gene therapies and the plasmid DNA that is one of the starting materials in viral vector production.
Executive Director of IDA Ireland Mary Buckley said: “Today’s announcement by MeiraGTx is closely aligned with IDA Ireland’s strategy for the Life Sciences sector, and indeed in winning jobs and investment in regional locations. This investment is an emergent area within Biopharma, and strongly endorses the Midwest and Ireland’s reputation as a key location for the next generation of biopharmaceutical manufacture.”
The MeiraGTx project in Shannon will create new highly skilled biopharma jobs in the region with a team to include bio-process scientists, engineers and technicians for manufacturing, engineering, technical and quality roles.
Shannon Group has welcomed the announcement.
Welcoming Meira to Shannon, Rose Hynes Chairman of Shannon Group, stated that their decision to locate in Shannon Free Zone and the anticipated job creation validates the decision by Shannon Group to commence this development programme in the Shannon Free Zone and comes on top of significant investments by Jaguar Land Rover, Edwards Lifesciences, Engine Lease Finance and GE Sensing in commercial property solutions developed by Shannon Group in the Shannon Free Zone.
Two new leading-edge facilities are currently under construction and are being developed by Shannon Group’s subsidiary company, Shannon Commercial Properties. They will comprise 94,000 sq ft in two separate buildings designed to meet global regulatory requirements, including the cGMP, required by the U.S. Food and Drug Administration (FDA).
IDA Ireland welcomes MeiraGTx announcement of major expansion of #Shannon facility https://t.co/OkTh8BjygI
— IDA Ireland (@IDAIRELAND) August 6, 2020