Glasgow, Scotland. Sistemic Ltd. today announced the launch of its first predictive diagnostic product for protein production utilising its novel miRNA technologies including SistemQC™, SistemSeek™ and SistemExpress™. The introduction of the first product in the new SistemCheck™ range will be for the prediction of indoleamine 2,3-dioxygenase (IDO) production in cells.
The product will use a small panel of miRNAs which will be quantified and then, using an algorithm designed from internal research at Sistemic, give a prediction of IDO production before any further manipulation of the cell in question takes place. The trials so far undertaken during the development process indicate that the production level can be predicted with a high level of accuracy.
IDO production by mesenchymal stromal/stem cells (MSCs) has been the subject of significant research over recent years. Human MSCs produce IDO which suppresses T-cell proliferation in vitro and in vivo leading to their anti-inflammatory effects in immune conditions such as Graft vs Host Disease. IDO production is a surrogate measure for the in vitro immunosuppressive potential of MSCs from different donors. However, IDO induction is known to significantly vary between MSCs from different donors and therefore impact on potential clinical efficacy. A simple, rapid and early stage assay predicting IDO production in cells that allows for donor optimisation prior to any form of manipulation will be highly beneficial and transformational for clinical utility.
The industries using cells, in particular biologics manufacture and Cell and Gene Therapy (CGT), have been seeking more predictive tests to improve these complicated and very expensive production processes and to make the processes more robust, standardised and efficient. The introduction of this product which will accurately predict protein production from a cell prior to any form of manipulation is a major breakthrough and signals a significant advance for a wide range of industries where cells are used as either the producer of a product or used as the product themselves.
The ability to accurately predict the protein output of a cell will have transformational impacts on the entire bioproduction industry. Many of today’s blockbuster drugs are biologics. With escalating costs and challenges to reimbursement the ability to preselect cell populations where the level of production of that cell can be accurately predicted will lead to significant improvements in production efficiency and cost reductions which should enhance the ability for broader use of these life changing medicines in the future.
Jim Reid, Chairman and CEO stated “It has been a long term goal of Sistemic to move its range of miRNA-based technologies, which are used by many of the world’s leading CGT and Regenerative Medicine companies, into a range of products which would offer prediction of cellular (phenotypic) outcomes. The SistemCheck™ IDO product represents the first of these and we are very excited at the prospects for a range of industries where cells are used, often in a way where little is known about the expected outcome until the final step in a long, complicated and expensive process. Being able to accurately predict outcome with a very high degree of certainty will be a major breakthrough for the industry and one which should offer great benefits for those industries as well as for the people and patients who use their products. More controllable and efficient production processes should hopefully result in better products and reduced cost.”
Dr David Mallinson, Vice President of Scientific Operations stated “The critical role played by miRNAs in regulating phenotypic outcome means that Sistemic has a unique set of data which can be developed into predictive diagnostic products for the Cell Industry. This industry has suffered from a lack of predictive analytics and with this introduction we are hopefully going to see a step change in the ability of this industry to take the next stage in its development and allow higher efficiencies and much greater controllability.”
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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