Availability of GMP grade iPS cells expected to reduce time to clinic
London and Edinburgh, UK - 11 September 2013: The Cell Therapy Catapult, which is focused on the development of the UK cell therapy industry to increase the nation's health and wealth, and Roslin Cells, an expert in the production of stem cells, are partnering to establish a source of clinical grade induced pluripotent stem cells (iPS1) banked according to Good Manufacturing Practice (GMP) in the UK. With iPS cells gaining in importance as a source of new therapies and the first products soon to enter trials, establishment of the cell bank with an initial £2m investment provides the UK with an important source of iPS cells acceptable to the regulatory authorities.
These iPS cell lines will be available for clinical research in both academia and industry, with the initial six expected to be available by the end of 2014. Clinical grade iPS cells will be isolated and banked in compliance with GMP in the manufacturing facility at Roslin Cells in Edinburgh. From these banks, research grade lines will be created and made available for early stage work and preclinical research. This means that when a cell therapy has been developed, researchers will be able to move to GMP grade cells confident that they will be acceptable for clinical trial.
iPS cells were discovered in 20062, and their significance in the development of new therapies is based on their ability to differentiate into any cell type, opening up the treatment of a large range of diseases. They are produced by reprogramming somatic cells, so they can be produced from a patient's own cells or obtained from donors who have the blood and tissue types that can provide a good match to recipients. Human iPS-based cell therapies are believed to be around 10 years away from launch, with clinical trials starting in Japan next year, and over 40 preclinical studies underway.
Keith Thompson, CEO of the Cell Therapy Catapult, said “The GMP iPS bank provides researchers with a much-needed capability to accelerate entry into clinical trial, ultimately bringing a new generation of therapies to patients. With the Cell Therapy Catapult focused on building the industry and Roslin Cells as its partner in this initiative, we believe it will play a key role in generating health and wealth for the UK.”
Aidan Courtney, CEO of Roslin Cells, added "Roslin Cells is delighted to be involved in this timely initiative. With many iPSC-based therapies now in development, it is essential that researchers have access to cell lines which meet the required stringent regulatory standards. By combining the resources and expertise of the Cell Therapy Catapult with our own stem cell production capabilities, we will be able to create a substantial resource in a relatively short period of time.” --ENDS--
1 Access our iPS backgrounder here
2 iPS cells were discovered by Dr Shinya Yamanaka in 2006, leading to the award with Professor Sir John Gurdon of the 2012 Nobel Prize for Physiology or Medicine for the discovery that mature cells can be reprogrammed to become pluripotent
For more information, please contact:
Cell Therapy Catapult
Keith Thompson, CEO +44 (0)207 1883428
Emma Palmer Foster, Strategic Communications Consultant +44 (0)7880 787185
Technology Strategy Board (for Catapult programme)
James Easey, Media Relations
James.Easey@tsb.gov.uk +44 (0)7557 086952
Media Relations Team +44 (0)7766 901150
Roslin Cells Ltd
Aidan Courtney +44 (0)131 658 5180
Notes to Editors
About the Cell Therapy Catapult
The Cell Therapy Catapult is a centre of translational excellence for cell therapy and regenerative medicine. Its vision is for the UK to be a global leader in the development, delivery and commercialisation of cell therapy, making it a location for business start-up and growth. Based in London at Guy's Hospital, the centre plans to take products into early clinical trials, providing clinical, technical, manufacturing and regulatory expertise and access to the NHS. There will be a focus on collaboration and lowering barriers to investment and funding, and operations will grow rapidly throughout 2013. The global cell therapy industry was estimated to have an turnover of $1bn in 2011 and is estimated to grow to $5bn by 2014 (Mason Regen Med 5(3) 2010, Mason Regen Med 6(3) 2011). For more information please go to ct.catapult.org.uk
Catapult centres are being established by the Technology Strategy Board, as a new addition to its range of programmes to stimulate innovation. They are places where the best of the UK’s innovative businesses and researchers work together to bring new products and services more quickly to commercialisation. Focusing on areas with great market potential, Catapults will open up global opportunities for the UK and generate economic growth for the future. In addition to the Cell Therapy Catapult, catapults for High Value Manufacturing, Offshore Renewable Energy, Satellite Applications, the Connected Digital Economy, Future Cities and Transport Systems are being established.
About the Technology Strategy Board
The Technology Strategy Board is the UK’s innovation agency. Its goal is to accelerate economic growth by stimulating and supporting business-led innovation. Sponsored by the Department for Business, Innovation and Skills (BIS), the Technology Strategy Board brings together business, research and the public sector, supporting and accelerating the development of innovative products and services to meet market needs, tackle major societal challenges and help build the future economy. For more information please visit www.innovateuk.org.
About Roslin Cells
Roslin Cells is a leader in the development of cell therapies and provides Good Manufacturing Practice (GMP) manufacturing services for cell therapy products and mammalian cell banks for clinical use. Roslin Cells also provides a range of pluripotent stem cells for clinical use and research customers. Based at the Edinburgh BioQuarter within the Scottish Centre for Regenerative Medicine (SCRM), the Company operates a state of the art, seven clean room GMP Cellular Therapy manufacturing facility in partnership with the Scottish National Blood Transfusion Service (SNBTS). Roslin Cells supports its clients to the clinic by providing full process development and translational capabilities including early phase GMP manufacturing of cellular therapies for clinical trials. The Company also operates an induced pluripotent stem cell (iPSC) facility in its research laboratories which serves the needs of prominent industry, academic and clinical researchers who are breaking new ground in cellular models for research, drug discovery and the next generation of cells to be manufactured for cellular therapies. www.roslincells.com