The company’s Cell & Gene Therapy Centre can now offer a full range of GMP services

Press release: eXmoor pharma, the full-service cell and gene therapy (CGT) manufacturing partner, announced it has received a Manufacturing and Import Authorisation for Investigational Medicinal Products (MIA(IMP)) licence from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), authorising the manufacture of good manufacturing practice (GMP)-grade cell and gene therapy materials for use in clinical trials.

This follows a successful inspection of eXmoor’s Cell & Gene Therapy Centre in Bristol, marking the end of a two-year project to design, build and bring online a 65,000 state-of-the-art advanced therapies manufacturing facility.

The licence is a major milestone in eXmoor’s 20-year journey from a consultancy into a full-service, global CGT contract development and manufacturing organisation (CDMO). The Cell & Gene Therapy Centre has been designed in-house by eXmoor as a flexible and scalable manufacturing hub, with integrated process development and analytical labs, four GMP clean rooms and fill/finish capability.

It can support scale-up, optimisation and manufacture of cell therapies, RNA therapies and viral vectors, with up to 2 x 200L bioreactors and multiple autologous cell therapy stations per suite. In addition, the cutting-edge zero-carbon facility relies entirely on solar technology and heat pumps.

“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,” said Angela Osborne, CEO of eXmoor pharma.

Source : https://pharmatimes.com/news/exmoor-pharmas-manufacturing-facility-receives-licence-from-mhra/