The company’s Cell and Gene Therapy Center is now capable of providing a full range of GMP services.
press release: eXmoor pharma, a full-service Cell and Gene Therapy (CGT) manufacturing partner, has announced that it has received an Investigational Medicines Manufacture and Import Authorisation (MIA (IMP)) license from the UK Medicines and Healthcare products Regulatory Agency (MHRA), authorising it to produce Good Manufacturing Practice (GMP) grade cell and gene therapy material for use in clinical trials.
This follows the successful testing of eXmoor’s Cell and Gene Therapy Centre in Bristol, and marks the end of a two-year project to design, build and bring online a 65,000 state-of-the-art advanced therapy manufacturing facility.
This license marks a major milestone in eXmoor’s 20-year journey as it evolved from a consulting company to a full-service global CGT contract development and manufacturing organization (CDMO). The Cell and Gene Therapy Center was designed in-house by eXmoor to be a flexible, scalable manufacturing hub with integrated process development and analytical labs, four GMP cleanrooms and fill/finish capabilities.
With up to 2 x 200L bioreactors and multiple autologous cell therapy stations, it supports the scale-up, optimization and manufacturing of cell therapies, RNA therapies and viral vectors. Additionally, the state-of-the-art, zero-carbon facility relies solely on solar technology and heat pumps.
“This marks the start of a new era of growth for the company, as we provide a comprehensive range of development, manufacturing and specialist consultancy services to support cell and gene therapy developers from research to market,” said Angela Osborne, CEO of Exmoor Pharma.
