Cell Therapy Catapult & Roslin Cells to create clinical grade stem cells to accelerate research into new treatments

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 (iPS) 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 2006, 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.”