EMD Millipore and Sistemic Collaborate to Identify Control Markers for Stem Cell Production

• Companies jointly developing kits for quality control of in vitro stem cell cultures
• Partnership combines Sistemic's microRNA solutions with EMD Millipore's stem cell expertise
• Collaboration to advance stem cell-based therapeutics toward clinical testing

Glasgow, UK, and Billerica, MA, November 1, 2012 / B3C newswire / - EMD Millipore, the Life Science division of Merck KGaA, Darmstadt, Germany, today announced a new initiative with Sistemic Ltd., a leading provider of microRNA-based problem-solving services and kit-based products. The two companies are jointly developing a proprietary monitoring methodology utilizing Sistemic's microRNA marker detection capability to enable consistent growth of stem cells in EMD Millipore's Mobius^® CellReady platform. These markers could also be incorporated into a commercially-available kit for quality control of stem cells in culture.

"To advance the progress of stem cell products toward clinical use, it is critical to ensure the consistency and quality of large-scale culture systems," said Robert Shaw, Commercial Director of EMD Millipore's Stem Cell Initiative. "We are excited to be partnering with Sistemic, as the company's leading microRNA-based solutions will help us continue our efforts toward the commercialization of stem cell processing."

"We are delighted to enter this collaborative arrangement with EMD Millipore," commented Sistemic Chairman and CEO Jim Reid. "The fact that EMD Millipore has chosen Sistemic as its collaborative partner is yet another validation of our ground-breaking research and ability to develop systems for quality control of stem cells, and other mutually beneficial products and programs."

This announcement was made at the Second Annual Stem Cell Meeting on the Mesa, of which Sistemic and EMD Millipore are co-sponsors, October 29-31 in La Jolla, California.

For more information about EMD Millipore's Stem Cell Initiative, please visit:www.emdmillipore.com\stemcells.

Successful trade mission to Japan and Korea yields new business opportunities for Sistemic

26 March 2012: Sistemic, UK:  Sistemic Ltd, Glasgow, concluded a successful trade mission to Japan and Korea in February 2012. Verna McErlane, Director of Commercial Operations, presented the company’s miRNA-based approach to a receptive group of businesses and research institutions in Tokyo, Osaka, Kyoto, Seoul and Jeonju. The Japan portion of the trip was planned by the Scottish and Japanese offices of Scottish Development International (SDI).

 During the visit, Sistemic met with both existing and potential clients, and participated in a number of seminars and partnering sessions. Verna McErlane, Director of Commercial Operations, Sistemic, explained: “As the trade mission progressed, it became clear that the partnership model for drug development features highly in the plans of the pharma industry there. It was exciting to have the chance to present how the world’s second largest pharma market will benefit from Sistemic’s unique miRNA profiling products and services.”

Sistemic is pursuing an active global expansion plan for the business. Jim Reid, Sistemic’s CEO commented: “Pharma companies are looking to access technologies on a global basis, so it’s important Sistemic is recognised at this level. We are proud to have customers all over the US and Europe, as well as in Australia and Asia Pacific and we look forward to working closely with a number of new partners in Japan and Korea as a result of the trade mission.”

 During the visit, Sistemic presented its SistemQC product for use in cell characterisation and QC. This is of particular interest to anyone working on cell therapies, regenerative medicine and stem cells. SistemQC is a miRNA-based fingerprint approach that provides a powerful and informative way to characterise and monitor cells lines, including stem cells, for identity, purity, safety and differentiation staging. Sistemic also presented details of SistemRNA and how it is used in drug discovery and development. SistemRNA applies a compound-centric approach identifying drug effects by associative changes in miRNA express profiles and its analysis in context. The addition of SistemRNA to the drug discovery toolbox can support strategic decision-making at key stages and maximise asset value.

Verna McErlane added: “The people we met in both countries were very welcoming and interested in innovative tools that can help them in their work. We are following up with a number of companies and planning return visits in June and September.”

For more information about Sistemic and it's products and services, visit: www.sistemic.co.uk

Sistemic to Work with TiGenix On Landmark EUR 5.9 Million, FP7 European Project Aiming at Developing an Innovative Rheumatoid Arthritis Cell Therapy Treatment Product

Glasgow, UK, February 7, 2012 / B3C newswire / - Sistemic is delighted to announce that its proprietary technology (SistemQC™) has been chosen to form a key part of the research and production process for a landmark multinational collaborative project led by TiGenix, Belgium and including partners from Spain, France, the Netherlands as well as the UK and Belgium. The project, REGENER-AR, will bring the first stem cell therapy treatment product for rheumatoid arthritis, Cx611, through final research and clinical development.

The proprietary SistemQC™ miRNA-based stem cell characterization and quality control tool-kit will provide important insights into process optimization and QC testing of TiGenix’s pioneering cell therapy product. This work is part of a larger collaborative effort led by TiGenix and funded by a EUR 5.9 million European Seventh Framework Programme (FP7) grant under the topic “Regenerative medicine clinical trials” within the Health theme.

SistemQC™ combines robust miRNA profiling with superior statistical analytics and multi-layered contextual analysis to generate a fingerprint of key miRNAs (kmiR™s). This approach provides a succinct read out on the status of the cells, with the added benefit of being able to interpret the underlying biological effects associated with any change observed. Additionally, the kmiR™ fingerprints can be adapted to a QPCR method for ease of integration into laboratory routine, and provide rapid testing. They can be used as a cell phenotype characterization tool in combination with a qualitative assessment of product cell composition, or to monitor product quality during scale-up and aid the selection of manufacturing process improvements.

Dr Vincent O’Brien, Sistemic’s Chief Science Officer said, “We are honoured to be working with TiGenix and Cellerix, its Spanish subsidiary as well as partners from all over Europe. Sistemic will provide in-depth product characterization data during the clinical trial with Cx611. This will be a critical part of the development and subsequent production process. We look forward to collaborating with all of the consortium members on this important project as we are supportive of the potential of cell therapy products to bring real benefits to those patients suffering from rheumatoid arthritis.”

The collaborative project, referred to as the REGENER-AR consortium, brings together 10 top-level research institutes, medical entities and biotechnology companies from Spain, France, the UK, the Netherlands and Belgium. The consortium has defined a clinical translational project with the aim of developing a broadly available, clinically applicable treatment for rheumatoid arthritis by exploiting human allogeneic mesenchymnal adult stem cells extracted from adipose tissue (eASCs).

Sistemic provides innovative miRNA-based products to the cell therapy, drug development and bioprocessing markets. The company’s pioneering approach enables companies to accelerate drug discovery and development programmes whilst reducing development risk. For further information visit: www.sistemic.co.uk

Sistemic is a registered trademark of Sistemic UK
SistemQC™ and kmiR™ are trademarks of Sistemic UK

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