CGT facility receives UK regulatory approval

Bristol, UK-based cell and gene therapy (CGT) manufacturing partner, eXmoor Pharma has been granted a 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.

The Manufacturing and Import Authorisation for Investigational Medicinal Products (MIA(IMP) was awarded following a two-year project resulting in a flexible and scalable manufacturing hub, with integrated process development and analytical labs, four GMP clean rooms and fill/finish capability.

The Cell & Gene Therapy Centre designed in-house by eXmoor, is also a zero-carbon facility relying 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 CEO Angela Osborne.  “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,” added Chief Technology Officer Lucy Foley.  “We are excited to begin manufacturing and helping new and existing clients to accelerate their products to patients faster.”

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