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CASE STUDY

Developing large scale manufacture and supply of cell and gene therapies

The Cell and Gene Therapy Catapult Manufacturing Centre facilitates collaborating companies to produce living medicines at scale, supporting clinical trials and commercial supply.

TWO
MHRA licences awarded to produce medicines at scale
£1Bn
raised in investment for SMEs
1500
jobs created in the sector
200%
increase in company numbers

The agreement with CGT Catapult enables us to meet our immediate clinical trials needs and have the flexibility of both our own dedicated manufacturing space and access to an established supply chain at one of the world’s premier centres for cell and gene therapy development

Garry Menzel Ph.D
President & CEO, TCR2 Therapeutics

Supporting companies scale in the cell and gene sector

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.