New life-changing cell and gene therapies for use in health services around the world will be produced in Stevenage by innovative biotech firms as the Cell and Gene Therapy Catapult (CGT Catapult) is granted new licences.
The licences, awarded by the Medicines and Healthcare products Regulatory Agency (MHRA), will help these companies collaborating with the CGT Catapult at the Stevenage manufacturing centre 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 world-leading 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 best-in-class infrastructure to help collaborators develop and commercialise medicines at the cutting edge of medical science.
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 over 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 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 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.
The go-ahead to make cell and gene therapies that could ultimately save lives is a great boost for the area, but also shines a light on the whole of the UK as an attractive place for this innovative industry to thrive.
This project supports the ambition of our modern Industrial Strategy to maintain the UK’s standing as a world leader in research and innovation.
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.
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.