In August 2018, the Cell and Gene Therapy Catapult’s Manufacturing Centre was awarded two licences from the MHRA, allowing collaborating companies to produce living medicines at scale to support clinical trials and commercial supply.
The centre, which is currently supporting UK and US companies, has a unique operating model which 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 Cell and Gene Therapy Catapult experts across scientific research, manufacturing, supply and regulation. In March 2019, Autolus were the first collaborating company to receive a Manufacture of Investigational Medicinal Product (IMPD) license and are now producing therapies at the centre for clinical trials.
TCR2 Therapeutics, a clinical-stage immunotherapy company pioneering the next generation of novel T-cell receptor (TCR) based therapies for solid tumours and blood cancers, is the first U.S. company to develop its global manufacturing systems and establish operations at the centre to support their immediate clinical trial needs, highlighting its flexibility, access to an established supply chain and the UK ecosystem.
SME collaborators have raised £1bn in investment, whilst the cell and gene therapy sector has seen the creation of 1500 jobs, company numbers have grown from 22 to 70 and clinical trials have increased from 21 to 93. This process has succeeded in driving new therapies and is on track to create 18,000 jobs by 2035.