Glasgow, SCOTLAND. Sistemic Ltd. is excited to announce significant progress with the development of a miRNA-based assay for assessment of pluripotent stem cell (PSC) contamination in derived cell therapy products. The development is being undertaken in conjunction with LGC, the UK National Measurement Laboratory and Designated Institute for chemical and bio-measurement.
The work at Sistemic is being supported by the UK’s innovation agency, Innovate UK, under the “Analysis for Innovators” grant. Significant progress has already been made in optimising the assay to improve sensitivity and performance. Based on this progress, testing of assay with clinical products is planned in Q4 2017, with the assay being on course for early release at the beginning of 2018.
Jim Reid, CEO stated "this is a major step forward in the assessment of cellular contamination and will be a great help to companies developing iPSC-derived products. It is also the second product in our SistemCheck™ range and continues our development of novel products and other analytical technologies targeted at the Cell and Gene Therapy sector. This sector will make a significant contribution to the treatment of many diseases in the future but the industry also needs to have robust analytical products and this is what SistemCheck™ can bring”
David Mallinson, VP of Scientific Operations added "We are delighted with the significant progress that has been made so far in further optimising the assay. The assay shows great promise and 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"
Potential partners interested in receiving further information on the availability of the test or to be part of an Early Access Programme should contact press@sistemic.co.uk
About Sistemic
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.
For more information contact: press@sistemic.co.uk
