eXmoor Pharma's Facility Scores Major MHRA Approval

eXmoor Pharma, a leading provider of cell and gene therapy (CGT) manufacturing services, has secured a Manufacturing and Import Authorisation for Investigational Medicinal Products (MIA(IMP)) licence from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). This authorisation allows eXmoor to produce GMP-grade cell and gene therapy materials for clinical trials.

This achievement follows a successful inspection of eXmoor’s new Cell & Gene Therapy Centre in Bristol, which culminates a two-year effort to design, construct, and launch a state-of-the-art facility dedicated to advanced therapies. Spanning 65,000 square feet, the centre represents a significant advancement in eXmoor’s evolution from a consultancy to a global CGT contract development and manufacturing organisation (CDMO) over its 20-year history.

The new centre, developed entirely by eXmoor, features a highly adaptable and scalable design. It includes integrated process development and analytical laboratories, four GMP clean rooms, and fill/finish capabilities. The facility is equipped to support the scale-up, optimisation, and production of cell therapies, RNA therapies, and viral vectors, with up to 2 x 200L bioreactors and multiple stations for autologous cell therapy. Additionally, the centre operates as a zero-carbon facility, utilizing solar technology and heat pumps.

Angela Osborne, CEO of eXmoor pharma, said “This marks the beginning of a new era of growth for [the company], now offering a complete set of development, manufacturing and expert consulting services that support cell and gene therapy developers from research to the market.”