The Cell and Gene Therapy Catapult today released their third annual survey of GMP cell and gene therapy manufacturing facilities in the UK.
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 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.