CDMO News

eXmoor Pharma Secures MIA(IMP) License from MHRA

  • eXmoor Pharma receives MIA(IMP) license from MHRA to manufacture GMP-grade cell and gene therapies for clinical trials.
  • New license follows a successful inspection of eXmoor’s Bristol Cell & Gene Therapy Centre, enabling expansion in the CDMO sector.

eXmoor Pharma has reached a key milestone by obtaining 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 permits the company to produce good manufacturing practice (GMP)-grade cell and gene therapy materials intended for use in clinical trials.

The license was granted following a thorough inspection of eXmoor’s Cell & Gene Therapy Centre in Bristol. The facility, built specifically for advanced therapy manufacturing, represents the culmination of a two-year project aimed at establishing a flexible and scalable hub capable of supporting a wide array of cell and gene therapy modalities.

This development underscores eXmoor Pharma’s transition from a consultancy firm to a global contract development and manufacturing organization (CDMO). The Bristol Centre is equipped with integrated process development and analytical laboratories, four GMP clean rooms, and fill/finish capabilities. It is designed to handle scale-up, optimization, and manufacturing of various therapies, including cell therapies, RNA therapies, and viral vectors, with bioreactor capacities up to 200 liters and multiple autologous cell therapy stations per suite.

“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 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.”

Lucy Foley, Chief Technology Officer of eXmoor Pharma, added, “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.”

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