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