The 65,000 sq ft facility will support the simultaneous production of multiple therapies for clinical trials.
In addition, the facility marks the final step in eXmoor’s expansion into a full-service CGT contract development and manufacturing organization (CDMO).
At Advanced Therapies 2023, Kate Fynes, CMC translation consultant at eXmoor, told BioPharma Reporter that the new facility was a significant milestone for the company.
“We can now offer support right across the board from consultancy through to early-stage clinical manufacture. The cost-saving and streamlining this can afford the client brings a lot of value. It is also awesome for the Southwest in general, eXmoor is attracting talent and helping foster an ecosystem within the ATMP space outside of the golden triangle,” she said.
“The hope is that, by setting up the manufacturing facility, it will attract other companies to the area and help to keep developing this area as a hot spot for CGT therapy development. We’ve got a pipeline of customers that are hoping to manufacturer in the facility – so having our license to manufacture approved and releasing the first product will be a tremendous milestone to reach.”
The cell and gene therapy centre houses specialized labs for clients’ process and analytical development, with the capability for technology transfer to GMP production on the same site.
The GMP area has several features, including four large, grade C processing modules with airlocks and process-agnostic design for both cell and gene therapy manufacturing.
The facility has also been designed with no fossil fuel usage on site, relying instead on solar technology and heat pumps.
eXmoor anticipates securing a Medicines and Healthcare products Regulatory Agency Manufacturing License in April 2024, allowing for the clinical manufacture of cell and gene therapies.
Angela Osborne, CEO of eXmoor, added: “The opening of this facility marks a landmark achievement for us, as we bring our 19 years of translation consulting and process development experience to directly enable the rapid development of life changing therapies in the UK and beyond. To date, we have completed more than 500 projects, including the design of 37 CGT manufacturing facilities. Our Cell and Gene Therapy Centre represents the culmination of all that experience.”
The company is now scheduling 2024 manufacturing slots.
