Cell and gene therapy: develop new treatments in the UK
Published 18 October 2018
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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.
The catapult:
- aims to build an £10 billion industry
- has invested £125 million in a development facility in London with 120 staff, and in a large scale manufacturing centre in Stevenage
- works with 200 commercial and academic partners from 24 countries
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.
The Cell and Gene Therapy Catapult manufacturing centre offers modular manufacturing facilities for advanced therapy developers.
Industry accesses expertise in cell tissue collection and logistics through NHS Blood and Transplant and the Scottish National Blood and Transfusion Service.
UK’s internationally recognised regulation and standards
The UK’s compliance culture is a major factor in enabling successful product development by:
- minimising the risk of potential supply disruption
- satisfying local and global market requirements
The Medicines and Healthcare Products Regulatory Agency (MHRA) provides pragmatic support and innovation when regulating for advanced therapies. The MHRA Innovation Office offers a regulatory ‘one stop shop’ for developers.
Global standards are set through the National Institute for Biological Standards & Control (NIBSC).
Contact Life Sciences Organisation (LSO)
LSO is made up of a mixed team of civil servants and private sector specialists based in the UK’s Department for International Trade (DIT).
It provides support for:
- UK life sciences companies doing business overseas
- foreign life sciences companies wanting to invest in the UK
Contact LSO for more information on commercial opportunities in the UK’s life sciences sector.
You can find out more about investing in the UK at great.gov.uk.