First U.S. company to choose Stevenage UK site as its global production development base.
TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage immunotherapy company developing the next generation of novel T cell receptor (TCR) therapies for patients suffering from cancer, today announced it has selected the advanced therapy medicinal products (ATMP) ecosystem in the United Kingdom (UK) to establish a site for global manufacturing systems and capabilities. TCR2 will work with Cell and Gene Therapy Catapult (CGT Catapult) at their Stevenage manufacturing center to produce its novel TCR therapies based on the company’s proprietary TRuC™ (TCR Fusion Construct) T cells.
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 centers for cell and gene therapy development. Having these advanced manufacturing facilities already in place allows us to set up quickly and draw on the expertise and support functions provided by CGT Catapult and the wider life science ecosystem around Stevenage to produce our novel TRuC-T cell therapies and ensure sufficient supply for our clinical program. The UK government has shown tremendous leadership in cell therapy manufacturing and we are delighted to be working with such a talented pool of experts.
The CGT Catapult manufacturing center was established to allow companies developing cell and gene therapies to manufacture at scale, to Good Manufacturing Practice (GMP) standards. The center, underpinned by support from CGT Catapult experts across scientific research, manufacturing, supply, and regulation, provides the required capabilities for manufacture at high throughput in GMP environment, in terms of raw materials supply, quality control testing, cryostorage, logistics, track and trace, and integration into the wider supply chain. In September 2018, the center was awarded commercial licenses by the UK Medicines and Healthcare Regulatory Agency (MHRA) allowing the go-ahead for production of medicines for use in patients.
We are delighted to welcome TCR2 Therapeutics as the latest pioneering company to use the CGT Catapult manufacturing centre as its base for producing advanced therapies. It’s fantastic that the appeal of our unique facilities – and the wider Stevenage biotech cluster – is being recognised beyond the UK, adding to the strong group of local companies already working with us. By next summer we will have doubled capacity to meet growing demand, further strengthening the UK’s position as the world’s most complete ecosystem for the development of cell and gene therapies.
TCR2 Therapeutics is the first U.S. company to establish manufacturing operations at the CGT Catapult manufacturing center in Stevenage, which was opened in April 2018 backed by more than £60 million of UK government investment as part of the Industrial Strategy Challenge Fund. TCR2 joins advanced therapy companies Adaptimmune, Autolus, Cell Medica, and Freeline. The rapidly developing Stevenage cluster of cell and gene therapy currently includes development facilities for five cell and gene therapy companies, novel technology companies, as well as facilities established by international supply chain companies such as General Electric and Thermofisher. Capacity expansion at the manufacturing center is already underway to support strong growth in the cell and gene therapy industry.