MHRA Grants MeiraGTx License for London Manufacturing Facility
June 21, 2018
Rare Daily Staff
The U.K.’s Medicines and Healthcare products Regulatory Agency granted MeiraGTx a Manufacturer’s Authorization for Investigational Medicinal Products, which allows the company to manufacture gene therapy product candidates in its current Good Manufacturing Practices-compliant manufacturing facility in central London.
Completed in early 2018, MeiraGTx’s 29,000 square-foot facility was designed to operate as a flexible and scalable manufacturing hub, housing two cell production suites and three separate viral vector production suites. The facility offers production of multiple product candidates in parallel, as well as sequentially at different scales.
“Manufacturing remains a significant bottleneck in the development and delivery of gene-based medicines to the market,” said Alexandria Forbes, president and CEO of MeiraGTx. “We believe this will allow us to become a bedrock of production and collaboration for those working in gene therapy and bioprocessing.”
The facility also incorporates an integrated analytical department, an in-house analytical tool kit, and a dedicated product fill-and-finish suite. MeiraGTx’s facility has been designed to meet MHRA, European Medicines Agency, and U.S. Food and Drug Administration regulatory standards.
“We understand how critically important and in-demand manufacturing is for the global cell and gene therapy industry,” said James Christie, senior vice president of manufacturing and supply chain of MeiraGTx. “With our capabilities to produce, scale and analyze product candidates, MeiraGTx is well positioned to expedite the delivery of potential therapies to researchers, physicians, and ultimately patients.”
June 21, 2018
Photo: Alexandria Forbes, president and CEO of MeiraGTx
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