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eXmoor pharma Expands into Full-Service Cell and Gene Therapy CDMO Partner with Opening of GMP Facilities

eXmoor pharma Expands into Full-Service Cell and Gene Therapy CDMO Partner with Opening of GMP Facilities

eXmoor pharma launched its new Cell and Gene Therapy Centre good manufacturing practice (GMP) facility to support the production of multiple therapies for clinical trials. The 65,000-square-foot facility is designed with the capacity and capability to help scale the next generation of CGTs for human trials and beyond. It is also the final step in eXmoor’s expansion into a full-service CGT contract development and manufacturing organization (CDMO).

“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 [United Kingdom] and beyond,” said Angela Osborne, CEO of eXmoor. “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 new facility based in Bristol was constructed in 14 months to fully expedite more GMP manufacturing facilities in the CGT space. The new Cell and Gene Therapy Center is specialized in labs for clients’ process and analytical development with the capability for technology transfer to GMP production on the same site.

The area includes:

  •     Four large, Grade C processing modules with airlocks
  •     Process-agnostic design for both cell and gene therapy manufacturing
  •     Complete segregation between processing modules
  •     Up to two-times 200L bioreactor scale for viral vector or allogeneic cell therapy manufacture or space for up to five autologous cell therapy stations
  •     Fully serviced with all GMP gas supplies for any cell/gene therapy process
  •     Uninterruptable power supply and emergency generator for electrical back up
  •     Expansion space of 12,000 sq ft for another nine suites to grow with eXmoor’s clients into scaled-up and -out manufacturing for pivotal trials and in-market supply
  •     6500 sq ft for process development, quality control, and analytical labs, with ‘same again’ expansion potential for additional manufacturing and commercialization partnerships.

The facility has also been designed with no fossil fuel usage on site, relying instead on solar technology and heat pumps.

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More news about: quality / gmp | Published by Manvi | October - 18 - 2023 | 412

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