MeiraGTx Announces MHRA Grants MIA (IMP) License for cGMP Manufacturing Facility in London, UK
MeiraGTx announced it has been granted a Manufacturer’s Authorization for Investigational Medicinal Products from the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA). The license allows MeiraGTx to manufacture gene therapy product candidates in their current Good Manufacturing Practices (cGMP) compliant manufacturing facility.
Completed in early 2018, MeiraGTx’s 29,000 square-foot facility located in central London was designed to operate as a flexible and scalable manufacturing hub, housing two cell production suites and three separate viral vector production suites, offering 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, Ph.D., president and chief executive officer of MeiraGTx. “We have strategically crafted in-house capabilities, encompassing both the manufacturing facility and hiring of an extremely talented team. We believe this will allow us to become a bedrock of production and collaboration for those working in gene therapy and bioprocessing. We are extremely grateful to have some of the industry’s best manufacturing experts leading our operations.”
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 (EMA) and U.S. Food and Drug Administration (FDA) regulatory standards.
“At MeiraGTx, we understand how critically important and in-demand manufacturing is for the global cell and gene therapy industry,” said James Christie, BSc, MBA, SVP 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. We are excited about the advantage this facility creates in helping us optimize the best potential therapies for patients.”