Roslin Cells Announces the Roslin Cell Therapy Partner Program

Roslin Cells Announces the Roslin Cell Therapy Partner Program

Edinburgh, UK, 04 October 2010 - Roslin Cells Ltd., a leading provider of clinical grade pluripotent stem cells, announced today the Roslin Cell Therapy Partner Program. This innovative program will assist researchers in commercial and academic organisations with world leading expertise in the biology of cells of a particular type to translate their research into cell therapies which could be applied in the regenerative medicine field.

Over the last four years, Roslin Cells has established itself as one of the few organisations capable of producing clinical grade pluripotent stem cells, the starting material for the cell therapies which are expected to be developed through the Partner Program. The company has also developed a methodology for research translation, and established clean room facilities within the Roslin Institute near Edinburgh.

Over the last decade, researchers in academic and commercial organisations have sought to discover how pluripotent stem cells can be subjected to directed differentiation to produce cells of a particular lineage. One of the major aims of much of this research is to use the differentiated cells in cell therapy. The vast majority of this work is undertaken in conventional research facilities using research grade materials. As such, the methods developed fall a long way short of meeting the demand of regulators such as the EMA or the FDA. The "translation" of research protocols to those which comply with Good Manufacturing Practice is not leading edge science, but is essential if the fruits of the research are to be applied in cell therapy. Furthermore the protocols must be applied to a starting material, ie the pluripotent stem cells, which have themselves been derived to GMP standards. The Roslin Cell Therapy Partner Program will provide researchers with access to both GMP grade pluripotent stem cells and expertise in protocol translation.

Aidan Courtney, CEO of Roslin Cells commented, "It would be hard to overestimate how much work is involved in moving from fundamental research to a regulatory-compliant process. At Roslin Cells, we have gone through this process to be able to produce GMP grade stem cells and are now working with a number of commercial and academic research groups on the development of new cell therapies. The Partner Program will allow us to build relationships with leading researchers in a much greater range of lineages. We can offer each Partner access to our cell lines and our expertise - with a particular focus on the European market. We can also provide access to the extensive clinical trial infrastructure which has been established in Scotland and elsewhere in the UK. Overall this will accelerate the development of new therapies in regenerative medicine."

Roslin Cells is already working on the development of several clinical grade cell lineages, including red blood cells, endothelium, and hepatocytes. Its CSO Dr Paul De Sousa noted "Realising the clinical translation of pluripotent stem cell research requires a broad spectrum of expertise that does not exist in a single organisation. At Roslin Cells we are committed to realising the promise of pluripotent stem cells in regenerative medicine in partnerships that will complement our quality assured good manufacturing practice expertise and cell products."

Roslin Cells Ltd was established in 2006 by the Roslin Institute with the support of the University of Edinburgh, the Scottish National Blood Transfusion Service and Scottish Enterprise. The company's core mission is to provide ethically sourced, pluripotent human cells manufactured to the highest quality available according to Good Manufacturing Practice (GMP standards). This level of quality is critical to their intended use in therapeutic applications. By operating to such high standards, Roslin Cells is able to supply our partners and collaborators, premier quality pluripotent cell lines that are extensively characterised and tested. Our cell lines form the basic material with which our collaborators can develop cell therapies for clinical applications. They also represent the ideal starting material for researchers engaged in discovery research. Roslin Cells is headquartered in Roslin, Midlothian, and is a not for profit organization. Further information can be found at .

For further information:

Roslin Cells Ltd Chief Executive Officer Aidan Courtney Tel +44 131 527 4243 Fax +44 131 527 4517 [email protected]