eXmoor Pharma’s GMP cell and gene therapy manufacturing facility receives license from MHRA
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)) license from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), authorizing the manufacture of good manufacturing practice (GMP)-grade cell and gene therapy materials for use in clinical trials. The licensure 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 license is a major milestone in eXmoor’s 20-year journey from a consultancy into a full-service, global CGT contract development and manufacturing organization (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, optimization 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 eXmoor pharma, 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. “As we develop new partnerships, we will expand GMP operations to pivotal and commercial scale within the facility that is designed to increase cleanroom capacity quickly and easily – but we will retain the same underlying commitment to collaboration and focus on achieving our client’s goals.”
“The Cell & Gene Therapy Centre– one of the largest of its kind in the UK – is ready to manufacture immediately, with GMP and quality teams in place and high customer demand for our capacity over the next 18 months” said Lucy Foley, eXmoor pharma’s Chief Technology Officer. “We are excited to begin manufacturing and helping new and existing clients to accelerate their products to patients faster.”
