High Quality hESCs
Another company in stem cell supply is Roslin Cells (www.roslincells.com), a not-for-profit company established in 2006 by Paul de Sousa, Ph.D., a former embryology team leader at the Roslin Institute (post-Dolly era) and now a principal investigator at the SCRM. Roslin Cells is focused upon derivation of research and therapeutic-grade hESCs in compliance with cGMP.
“Human ESCs are really an artifact of cell culture. They have a propensity to differentiate, which we have to control. If you modify the culture environment, the cells may adapt and undergo subtle changes, which might not be appreciated until you come to use them,” says Dr. de Sousa. Through addressing these challenges, Roslin Cells has already produced one definite cell line and has two more in the pipeline.
Meanwhile in January, ITI Life Sciences (www.itilifesciences.com) and Cellartis signed an agreement for the development of an automated process to produce large numbers of high-quality cells in a new Dundee-located facility. ITI Life Sciences is one of Scotland’s three Intermediary Technology Institutes (ITI; along with ITI Techmedia and ITI Energy).
The £9.5 million ITI Stem Cell Technologies program also involves the Universities of Dundee, Heriot-Watt, and Glasgow. “ITI Life Sciences helps to develop the life science industry within Scotland,” explains program manager Fergus McKenzie, Ph.D. “We look at the technology and research that already exists, along with what we are good at. Stem cells are therefore something that ITI wants to push forward in the marketplace.”
The program aims to render stem cells usable by general labs. At present, stem cells are difficult for even experienced cell biologists to handle and are slow to grow and divide. “We are looking at how to get hESCs growing, day in and day out, and how to automate the process to take out the human factor,” says Dr. McKenzie.
Cellartis already has all the QC that is needed to take this forward, with 30 different hESC lines in small-scale production. The company wanted to expand, so a division was relocated to Dundee. As a first step, a robot, which has not yet been used for hESCs, has been purchased for cell production. Meanwhile, a collaboration with the University of Glasgow will progress differentiation of the hESCs.
Scottish Biomedical (www.scottish-biomedical.com) has set up stem cell services to meet client demand for screening based on stem cells. Offering preclinical drug discovery services, it is currently looking at turning hESCs into neural cells and hepatocytes for development. CXR Biosciences (www.cxrbiosciences.com) specializes in toxicology and has a collaboration with Geron on developing hepatocyte-like cells for drug screening.
Angel Biotechnology, the manufacturing partner of the U.K. Department of Trade and Industry’s bioprocessing consortium for stem cell therapy, has also set up a facility in Edinburgh for GMP manufacturing of clinical trial material. Invitrogen, whose European headquarters is in Scotland, established a stem cell and regenerative medicine business unit here in 2005.
The Scottish Stem Cell Network (SSCN; www.sscn.co.uk) has the global outlook needed to develop this industry. It has strong links with similar organizations in Australia, Canada, California and is the cofounder of the International Consortium of Stem Cell Networks. “Our focus is to bring together the stakeholders in the industry—all who will be involved in translating the research to patient benefit,”explains executive director Marilyn Robertson.
The future for stem cells in Scotland looks bright, but challenges still remain. While SE has shown the Scottish Executive’s commitment to the field, the U.K. government as a whole has yet to fulfill financial promises made in its 2005 Stem Cell Initiative. Much hangs on how Phase I trials planned by companies like Geron and ReNeuron turn out, as failure to meet endpoints will surely put off investors. For the short term, marketing stem cells for drug discovery seems a worthwhile strategy. Transforming healthcare through stem cell therapy, however, may take a little longer.