Licences granted by the Medicines and Healthcare products Regulatory Agency (MHRA) to Cell and Gene Therapy Catapult (CGT Catapult) will allow new life changing cell and gene therapies for use in health services around the world to be produced by innovative biotech firms.
Current companies developing their manufacturing and supply systems at the centre include Autolus, Cell Medica, Adaptimmune and Freeline and the centre is already being expanded to meet demand.
The licences will help cell and gene companies collaborating with CGT Catapult at its Stevenage, UK manufacturing centre, to develop therapies that can progress faster to clinical trials and commercial supply.
More cell and gene therapies are becoming available for patients, and the new licences represent a significant step towards establishing the CGT Catapult’s manufacturing centre in Stevenage as a global hub for the production of advanced therapies.
The manufacturing centre, opened in April 2018, provides the rapidly growing global cell and gene therapy industry with the best-in-class infrastructure to help collaborators develop and commercialise medicines at the cutting edge of medical science.
The centre’s unique operating model allows collaborator companies to manufacture their therapies at scale, all to good manufacturing practice (GMP) standards and underpinned by end-to-end expertise and practical support from CGT Catapult experts across scientific research, manufacturing, supply and regulation.
Keith Thompson, CEO of CGT Catapult, commented: “The granting of these licences marks an important milestone for the CGT Catapult. It demonstrates how our Stevenage manufacturing centre is becoming one of the world’s leading facilities for the development and production of cell and gene therapies.
“The award of these licences in such a short timeframe is testament to the close engagement we have maintained with the MHRA in the past few years for the building of a facility that allows for this unique collaborator model and one which we will continue to foster as the manufacturing centre and its surrounding innovation cluster grows. We now look forward to working with our current collaborators as they leverage our licences to move towards production of the first batches of clinical materials.”
The licences have been awarded following inspection by MHRA and are the result of close engagement with the MHRA during the design, build and qualification of this unique facility. The centre employs a new manufacturing model to assist collaborating companies to manufacture their innovative cell and gene therapies supported by CGT Catapult.
The two licences are a Manufacturing and Importation Authorisation (MIA) and an MIA for investigational medicinal product (MIA IMP). These licences are an EU requirement for the production of commercial medicines for patient use or to support clinical trials.