eXmoor Pharma, a provider of cell and gene therapy manufacturing services, has achieved a significant milestone with the receipt of a Manufacturing and Import Authorization for Investigational Medicinal Products (MIA(IMP)) license from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). This authorization allows eXmoor to manufacture good manufacturing practice (GMP)-grade cell and gene therapy materials for use in clinical trials.  
 
The licensure follows a rigorous inspection of eXmoor’s Cell & Gene Therapy Centre in Bristol, a state-of-the-art facility that was designed and built specifically for advanced therapies manufacturing. This achievement marks the culmination of a two-year project to create a flexible and scalable manufacturing hub capable of supporting a wide range of cell and gene therapy modalities.  
 
The MIA(IMP) license represents a major milestone for eXmoor, which has evolved from a consultancy firm into a global contract development and manufacturing organization (CDMO) over the past two decades. The Cell & Gene Therapy Centre features integrated process development and analytical laboratories, four GMP clean rooms, and fill/finish capabilities. The facility is designed to accommodate 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 to its advanced manufacturing capabilities, the Cell & Gene Therapy Centre is committed to sustainability. The facility relies entirely on solar technology and heat pumps, making it a cutting-edge, zero-carbon operation.  
 
“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.”