Sistemic and leading CDMO, Progenitor Cell Therapy (PCT) initiate study on novel stem cell characterisation technology

Sistemic Limited (Sistemic), the miRNA profiling company with facilities in Glasgow, Scotland and Boston, announced today the signature of an agreement to allow Progenitor Cell Therapy (PCT), Mountain View, CA, and Allendale, NJ, USA, a subsidiary of NeoStem, Inc, New York, to initiate evaluation studies on Sistemic’s SistemQC™ stem cell characterisation technology.

The studies have been designed to allow PCT to evaluate the broad applicability of SistemQC™ technology in stem cell characterisation employing Sistemic’s patented miRNA profiling system and proprietary analytical approaches to produce miRNA panels, termed Key miRNAs or KmiRs™, which PCT may look to employ in the future in process optimisation and cell characterisation.

Jim Reid, Chairman and CEO, Sistemic stated that “PCT is one of the world’s leading contract development and manufacturing organisations (CDMOs) and, in fact, the only CDMO that can count a client with an FDA approved cell therapy (CT) product. It is a great achievement for Sistemic to start working with such a progressive and sector-leading company. We aim to assist PCT in developing a more precise understanding of CT products and thereby help the industry to more rapidly bring effective CT products to market. The CT industry has incredible promise and could be transformational in terms of how we treat a number of diseases that have a huge impact on individuals and healthcare systems alike. In working with PCT we see a clear opportunity to make a significant impact in this vital therapeutic sector.”  

Dr. Timothy C. Fong, PCT’s Vice President of Technology and Product Development, added, “We are pleased to work with Sistemic to develop assays to better define our developmental cell therapy products. This technology complements our current efforts and should strengthen our understanding of what cells look like and how they function.”

About Sistemic Ltd

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™.

More information is available at http://www.sistemic.co.uk

About Progenitor Cell Therapy

Progenitor Cell Therapy, LLC, (“PCT”) a wholly owned subsidiary of NeoStem, Inc., is a leading CDMO in the cellular therapy industry. Since its inception in 1997, PCT has provided pre-clinical and clinical current Good Manufacturing Practice (“cGMP”) development and manufacturing services to over 100 clients advancing regenerative medicine product candidates through rigorous quality standards all the way through to human testing. PCT has two cGMP, state-of-the art cell therapy research, development, and manufacturing facilities in New Jersey and California, serving the cell therapy community with integrated and regulatory compliant distribution capabilities.  Its core competencies in the cellular therapy industry include manufacturing of cell therapy-based products, product and process development, cell and tissue processing, regulatory support, storage, distribution and delivery and consulting services.  www.pctcelltherapy.com

Sistemic Poster Winner at World Stem Cell Summit 2012

Dr. David Mallinson, Senior Staff scientist at Sistemic attended the World Stem Cell Summit in West Palm Beach, Florida, on December 3-5th 2012.  We are thrilled to announce that David won the Best Poster of the many posters that were presented over the 3 days of the busy international meeting which was judged by a prestigious panel of Cell Therapy Experts.  So well done David!

David commented 'The 3 day World Stem Cell Summit was an extremely informative meeting with sessions covering all stem cell topics and with attendance of many of the big players - both from academia and commercial organisations. Being awarded the Best Poster was very exciting and rewarding, and highlights the importance of cell characterisation to the cell therapy field and Sistemic's role as a leader in this area. Thank you to the organisers for awarding Sistemic this prestigious prize. It’s a great way for the team to end a successful 2012.”

David presented Sistemics work on using their novel SistemQC™ methodology to use miRNA-based profiling, analysis & interpretation to sensitively characterise stem cells as well as give a robust read out on quality control [A broadly applicable miRNA-based tool for stem cell characterisation & quality control’].  Sistemic is proud to say that the SistemQC methodology is being widely adopted globally by those that are developing Cell Therapies as well as those developing cell models or disease models for drug screening. For more information about SistemQC and its applications please get in touch at: info@sistemic.co.uk.

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.