Glasgow, Scotland Sistemic Ltd announced today the award of an Innovate UK grant to further develop, to a market-ready stage, its groundbreaking prototype microRNA-based assay for accurate assessment of pluripotent stem cell contamination in derived cell therapy products.
Sistemic will be partnered in this project by LGC, the UK National Measurement Laboratory and Designated Institute for chemical and bio-measurement.
Cell therapies are seen as the future of treatment in a number of therapeutic areas including diabetes and cardiovascular disease and are expected to revolutionise medical care for a range of currently untreatable diseases. Cell therapies are increasingly using pluripotent stem cells (PSCs) to generate derived cell therapy products. However, PSCs, by their nature, have the potential to form tumours which raises concerns around PSC-derived cell product safety. Therefore, there is a need to demonstrate, sensitively, quickly and accurately, the level of contaminating pluripotent stem cells in a derived cell therapy product. Sistemic has developed a prototype product based around miRNA biomarkers to detect contaminating pluripotent stem cells in a derived cell therapy product in a simple, highly sensitive and rapid test format. This partnership will support Sistemic in order to further develop their prototype product and make it ready for the rapidly developing market in PSC-derived cell therapy products
Sistemic will be supported by the UK’s innovation agency, Innovate UK, under “The Analysis for Innovators” grant.
Jim Reid, Chairman & CEO, Sistemic
“This is great news for Sistemic and supports the innovative position of our technologies and the unique value they can offer in the stem cell and gene therapy fields. Cell therapy products will be transformational in the treatment of many diseases but without adequate manufacturability and quality control these exciting products will fail to deliver on their promise. This development offers a major step forward in the journey of these exciting products to industrialisation, commercialisation and subsequent successful and safe medical use.”
David Mallinson, Vice President of Scientific Operations, Sistemic
“We are delighted to be working with LGC, and utilising their expertise as the National Measurement Laboratory for chemical and bio-measurement. The successful outcome of this project has the potential to facilitate the clinical progress of pluripotent stem cell-derived cell therapy products, allowing them to be developed to safer clinical products more quickly.”
Carole Foy, Principal Scientist, LGC
“We are very pleased to be able to provide measurement support to Sistemic through this project. Advances in the stem cell and gene therapy fields are offering unprecedented opportunities for improving human health. However, safe and efficient use of such therapies is heavily regulated and reliant on the development of robust measurements to assess product purity within allowable limits. The methods under development by Sistemic will be a major step forward in the field and LGC is proud to be offering support.”
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 and Gene 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. Furthermore, cell products in the later stages of clinical development benefit from SistemQC™ miRNA-based profiling approach in facilitating patient stratification and monitoring the response to the treatment. 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.
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LGC is an international life sciences measurement and testing company with leading positions in growing markets. LGC provides a range of measurement products and services which underpin the safety, health and security of the public, including reference materials and proficiency testing, genomics reagents and instrumentation, and expert sample analysis and interpretation. LGC serves customers across a number of end markets including Pharmaceuticals, Agricultural Biotechnology, Diagnostics, Food, Environment, Government and Academia.
LGC’s headquarters are in London and the company employs over 2,600 people, operating out of 22 countries worldwide. Its operations are extensively accredited to international quality standards such as ISO/IEC 17025, ISO 13485, ISO 9001, GMP, GLP and ISO Guide 34.
With a history dating back to 1842, LGC has been home to the UK Government Chemist for more than 100 years and is the UK National Measurement Laboratory and Designated Institute for chemical and bio measurement. LGC was privatised in 1996 and is now owned by funds affiliated with KKR.
For more information, please visit www.lgcgroup.com