The production of new cell and gene therapies at a manufacturing site in Stevenage - for use in health services around the world - has been given the green light by the Medicines and Healthcare products Regulatory Agency (MHRA).
These MHRA has issued two licences - a Manufacturing and Importation Authorisation (MIA) and an MIA for investigational medicinal product (MIA IMP) - which fulfill an EU requirement for the production of commercial medicines for patient use or to support clinical trials.
The move enables firms working with the Cell and Gene Therapy Catapult at its new manufacturing centre in Stevenage to develop therapies that can progress faster to clinical trials and commercial supply.
The licenses are the result of “close engagement with MHRA during the design, build and qualification” of the centre, which opened in April this year providing the 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,” according the CGT Catapult.
The centre’s unique operating model allows collaborator companies to manufacture their therapies at scale with exepertise and practical support from CGT Catapult experts across scientific research, manufacturing, supply and regulation, it said.
“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,” commented Keith Thompson, chief executive of CGT Catapult.
“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 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,” added life sciences minister Lord Henley.
“This project supports the ambition of our modern Industrial Strategy to maintain the UK’s standing as a world leader in research and innovation.”
Companies currently 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 CGT Catapult said.