The Cell and Gene Therapy Catapult today released their third annual survey of GMP1 cell and gene therapy manufacturing facilities in the UK. The review summarises the capability and capacity of all cell and genetherapy manufacturing facilities in the UK that hold an MHRA-licence. The survey, initiated in 2013 has continued annually following a recommendation by the UK government House of Lords 2013-14 Regenerative Medicine report.
The report highlights a number of key changes in the cell and gene therapy manufacturing landscape over the last 12 months, including:
- A continued increase in the number of GMP manufacturing facilities; 22 facilities in 2016, rising from 18 in 2015 and 13 in 2014. Of this increase, 3 are gene therapy manufacturing facilities and an additional facility in cell therapy.
- An increase in the number of people employed across UK cell and gene therapy manufacturers by a further 20% – from 324 to 391.
- An increased geographical spread of facilities throughout the UK. New additions for 2016 were based in London, Glasgow, Oxford and Birmingham.
- A 9% increase in total clean room footprint for cell therapy facilities, now totalling nearly 1900m2, whilst gene therapy clean room footprint almost trebled to more than 2400m2.
“Ensuring our manufacturing capability and capacity is continuing to grow is critical to the further development of a world leading cell and gene therapy industry for the UK. This is why we were asked by Government to produce these annual reviews, to ensure we are on track,” said Keith Thompson, CEO at the Cell and Gene Therapy Catapult. “The data in the 2016 report shows growth across all the markers that we analyse and forecasts a considerable increase again in the next 12 months. The opening of our own 7,200m2 cell and gene therapy facility in the UK next year will provide a step change to the UKs manufacturing offering that will help deliver revolutionary treatments for patients and assist companies to develop manufacturing in the UK.”
“The UK is making fantastic progress in manufacturing cell and gene therapies and shown great foresight by developing the Cell and Gene Therapy Catapult. It is vital that the UK has the capacity and skills needed to stay globally competitive in advanced therapy manufacturing,” said Ian McCubbin, SVP North America, Japan & Global Pharma Supply, GSK and chair of the Medicines Manufacturing Industry Partnership (MMIP). “The newly formed MMIP Advanced Therapy Manufacturing Taskforce, co-chaired by myself and George Freeman, Minister for Life Sciences, aims to build on this success and anchor the manufacturing and associated supply chain of advanced therapy products here in the UK.”
Notes to editors
- What is GMP?
GMP stands for Good Manufacturing Practice. Manufacturers of medicinal products for human use in the European Union are required to comply with the principles and guidelines of GMP, which are set out in Commission Directive 2003/94/EC. The principles of GMP serve as a quality assurance system that ensures medicinal products are consistently produced and controlled to the standards appropriate for their intended use.
- Read the press release and the House of Lords Committee report on regenerative medicine (2013) here.
- Find the previous GMP cell and gene manufacturing reports here.
About the Cell and Gene Therapy Catapult
The Cell and Gene Therapy Catapult was established in 2012 as an independent centre of excellence to advance the growth of the UK cell and gene therapy industry, by bridging the gap between scientific research and full-scale commercialisation. With more than 100 employees focusing on cell and gene therapy technologies, we work with our partners in academia and industry to ensure these life-changing therapies can be developed for use in health services throughout the world. We offer leading-edge capability, technology and innovation to enable companies to take products into clinical trials and provide clinical, process development, manufacturing, regulatory, health economics and market access expertise. We aim to make the UK the most compelling and logical choice for UK and international partners to develop and commercialise these advanced therapies. Regenerative medicine is one of the UK government’s “eight great technologies” that support UK science strengths and business capabilities. The Cell and Gene Therapy Catapult works with Innovate UK. For more information go to ct.catapult.org.uk or visit www.gov.uk/innovate-uk.