Guidance: Cell and gene therapy: develop new treatments in the UK

The UK is one of the best places in the world to develop, manufacture, and commercialise cell and gene therapies.

Nearly 1 in 3 of Europe’s 400 plus small and medium enterprises (SMEs) active in advanced therapy medicinal products (ATMPs) are based in the UK. The number of advanced therapy companies more than doubled between 2012 and 2015.

UK cell and gene therapy infrastructure for clinical research

The UK has an extensive clinical trial and test bed platform in the National Health Service (NHS). The NHS is the world’s largest integrated healthcare system, treating more than 60 million people.

With £1 billion annual invested annually, it provides a study support service for sponsors and contract research organisations (CROs). It currently hosts 60 cell and gene therapy trials.

UK platforms for cell and gene therapy technology and innovation

The UK Regenerative Medicine Platform operates 5 interdisciplinary and cross-institutional research hubs, and 5 aligned disease focused projects. The focus is on bridging the gap between scientific discovery and efforts to bring therapeutic products to the clinic. This work provides new tools, protocols, engineering solutions and knowledge to the community.

The Cell and Gene Therapy Catapult provides clinical trial, technical, manufacturing, regulatory, and market access expertise to advanced therapy developers and the wider supply chain.

Cell and gene therapy product development and manufacture in the UK

The UK’s offer is built on connectivity, innovation, talent, speed, compliance, value, and global access.

22 good manufacturing practice (GMP) facilities operate, an increase of 50% since 2013. There is an expanding commercial contract manufacturing capability and supply chain.