GLASGOW, Scotland, Oct. 14, 2013 /PRNewswire/ -- Scotland announced today that leading industry players, Sistemic and Roslin Cells, are going to work together with Scottish Development International to make the process of undertaking clinical trials in cell therapy easier, faster and more successful in reaching commercial realization. By bringing together unique Scottish investments such as Health Sciences Scotland, NHS Research Scotland, NHS Scotland and leading technology-based industrial partners, the country believes it can offer cell therapy companies a streamlined process for clinical trials. This will not only provide access to the right patients, but will support product development, characterization and potency development, making the regulatory process much easier.
$120 million has been invested into the Scottish stem cell cluster since 2004 to build state of the art clinical infrastructure and fund essential projects for this industry, such as manufacturing GMP grade hESC. Its commercial landscape has developed some of the most promising advancements in enabling technologies that have helped guide cell functionality and have created viable cell therapy products fit for the clinic. Scotland was selected as the location to conduct the UK's first approved ATMP stem cell clinical trial and already has active cell therapies in clinical practice, which include a pancreatic islet transplantation programme for Type 1 Diabetes and EBV Cytotoxic T Lymphocyte (CTL) bank for post-transplant lympho-proliferative disease.
"Thanks to the outstanding collaboration across NHS, academia, government and industry, Roslin Cells has been able to accelerate the expansion of its cell therapy manufacturing facilities based in the Scottish Centre for Regenerative Medicine. We and our NHS partners are working on the development of a number of cellular therapies which will enter clinical trial within Scotland and Europe in the coming years. This pipeline of new therapies demonstrates the exceptional resources Scotland has to offer," Roslin Cells' CEO, Aidan Courtney said.
The supportive regulatory environment in Scotland including high ethical standards for stem cell research activities, has ensured cell therapy companies have a streamlined clinical research approach that ultimately enables new medicines to get to market faster.
"Understanding the cell therapy products being placed into trial as well as selecting the right patient population is essential to conducting a successful clinical trial. Sistemic's SistemQC™ technology is already helping some of the world's leading cell therapy companies to achieve this and it seems fitting that, as a company founded in Scotland, we work with Scottish Development International, NHS Scotland and other leading companies to make Scotland the go to place for conducting trials in cell therapy of the highest caliber," Sistemic's CEO Jim Reid explained.
This week, a Scottish delegation including Roslin Cells and stem-cell focused companies such as Sistemic, will attend the Stem Cell Meeting on the Mesa conference in San Diego. Further information on Scotland's stem cell industry can be found at the Scottish Development International booth at the Stem Cell Meeting on the Mesa conference or visit www.sdi.co.uk/stemcells.
Sistemic's primary business is focused on providing innovative microRNA-based problem-solving services and kit-based products to areas of unmet need within Pharmaceutical, Biotechnology and the Cell Therapy research, development and manufacture markets. MicroRNAs are seen as the master controllers of a cell and as such Sistemic believe that they are providing instructive information on effects on a whole cell or organism rather than an isolated pathway. This system approach means that the data produced is more indicative of the biology and more diagnostic of actual effect. Their extensive suite of tools for the Cell Therapy community includes SistemQC™ which is used to characterise cells including stem cells (Cell Identity, Purity, Potency, and Safety) as well as monitoring the QC of production. In addition, the drug development markets are served through a range of products which include SistemTOX™, SistemKB™ and SistemRNA™. Sistemic has a worldwide customer base and a strong intellectual property portfolio.
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.
Roslin Cells was spun out of the world renowned Roslin Institute in 2006, through funding from Scottish Enterprise. Now 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 has a suite of development laboratories within the neighbouring Nine BioQuarter building, including an induced pluripotent stem cell (iPSC) facility. Roslin Cells is the only UK company providing research and clinical grade iPSC services to 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.
About Scottish Development International
Scottish Development International (SDI) is a partnership between the Scottish Government, Scottish Enterprise and Highlands and Islands Enterprise, which works to attract inward investment to Scotland and helps Scottish based companies to trade overseas. SDI can open doors to a huge range of opportunities in funding, new technology, R&D and training if international organizations are interested in operating, partnering or collaborating in Scotland. Potential investors receive free business and strategic advice from SDI and are supported in making crucial business contacts across Scotland.
SDI, together with the economic development agency Scottish Enterprise, are committed to investing in Scotland's stem cell and regenerative medicine industry to ensure Scotland can deliver a "one-stop shop" for companies wishing to develop and commercialize stem cell technologies. Whether you are a cell therapy company seeking a location to set up trials, build your own manufacturing facilities or access our supply chain services and people, Scotland has the infrastructure, supportive environment and company base to meet your needs.
SOURCE Scottish Development International