FLEXIBLE AND SCALABLE cGMP MANUFACTURING FACILITY
Manufacturing remains a significant bottleneck to the development and delivery of gene-based medicines to the market.
Located in central London, and under the direction of industry experts James Christie and Ian Delmage, MeiraGTx’s cGMP manufacturing facility is flexible and scalable, with eleven independent air handling units, two cell production suites and three separate viral vector production suites, which allows us to produce multiple product candidates in parallel, as well as sequentially at different scales. MeiraGTx’s manufacturing hub will also incorporate an integrated analytical department and in-house analytical tool kit as well as dedicated product fill-and-finish suite. This 29,000 sq ft facility is designed to meet MHRA, EMA and FDA regulatory standards, supporting MeiraGTx’s global view toward clinical development and commercialization.
This facility will provide a nucleus for the development of transformative processes and analytics as well as a center for collaboration with technology experts in Gene Therapy and Bioprocessing.
James Christie (BSc, MBA) is the SVP Manufacturing and Supply Chain for MeiraGTx. Prior to MeiraGTx, he was Head of Manufacture, Innovation and Project Director for the Medicines Manufacturing Industry Partnership (MMIP), employed by Association of the British Pharmaceutical Industry (ABPI). Prior to joining ABPI, he was responsible for setting up a patient-centric gene therapy supply chain at Oxford BioMedica plc. He has broad experience in operations in the US, Europe, Australia and Japan. James has also worked with BTG plc, Protherics, GlaxoSmithKline, Celltech Group and Centocor BV and the Institute of Cancer Research. He has extensive experience in the integration of group manufacturing operations following the acquisition of MacroMed by Protherics in January 2007 and the acquisition of Protherics by BTG in 2008. James sits on several key Steering Boards for Industry and government bodies.
Ian Delmage is Head of Quality for MeiraGTx. Prior to MeiraGTX, he was a Senior Compliance Professional, Global Pharma QA with Novartis. He was responsible for the performance of state-of-the-art GxP audits per the Novartis Quality System Standards and the current GxP regulations to ensure a high product quality standard and compliance with all applicable regulations. Audits performed on behalf of Pharma QA Compliance & Auditing include manufacturing sites, non-manufacturing sites, distribution centres, development centres, quality systems, other GxP areas (e.g. GCP, PV), third parties and suppliers. Prior to Novartis, he worked with Chorus Europe, Eli Lilly & Company, Emergent Biosolutions, UCB Celltech and Glaxo Wellcome. Ian received an MBA from Open University (UK).