Sistemic Ltd is a company whose primary business is focused on providing innovative microRNA-based tools for areas of unmet need within cell therapy research, development and manufacturing markets. Cell therapies are seen as the future of treatment and are expected to have great potential, revolutionising medical care capabilities in a range of chronic diseases, such as diabetes and myocardial infarction. A rapidly emerging field of cell therapy is to stimulate pluripotent stem cells (PSCs) to differentiate into the required therapeutic cell types. However, after infusion into a patient, residual contaminating PSCs in the final cell therapy product have the potential to form tumours, which is a safety issue. Regulatory bodies require cell therapy manufacturers to be able to assess the level of contaminating PSCs in derived cell therapy products. In conjunction with the National Measurement Laboratory at LGC (NML), we have a successful safety assay product -- SistemPSCCheck 1.0 - which was developed and validated to address this regulatory requirement for late differentiation stage PSC-derived cell therapies. However, in this developing field of medicine, due to their superior inherent biological properties, early differentiation stage PSC-derived products (progenitor cells - which share both stem cell and differentiated cell attributes) are now the derived cell type of choice to develop cell therapies. We have identified a specificity measurement problem with our assay in its current format that precludes its use with this derived cell type. By leveraging the key expertise and technologies available at the NML, Sistemic will work with the NML to further develop and optimise our current assay to a SistemPSCCheck 2.0 assay which is suitable for detecting residual contaminating PSCs in derived progenitor cell therapies. The outcome of this project will facilitate the safe clinical progress of PSC-derived progenitor cell therapy products to bring them to a clinical product more quickly. This will in turn result in patients getting quicker access to these novel therapies during clinical trial development phases, and ultimately, to a successfully launched clinical product and therefore improvements in quality of life.

Sistemic Ltd is a company whose primary business is focused on providing innovative microRNA-based tools for areas of unmet need within cell therapy research, development and manufacturing markets. Cell therapies are seen as the future of treatment and are expected to have great potential, revolutionising medical care capabilities in a range of chronic diseases, such as diabetes and myocardial infarction. Cell therapies are increasingly using pluripotent stem cells (PSCs) to generate derived cell therapy products. However, PSCs can form tumours, which is a safety issue requiring the need to demonstrate the level of contaminating PSCs. Currently there is no simple established way to assess contamination. We have developed a prototype product based around using biomarkers to detect contaminating PSCs in a derived cell therapy product. Innovate UK will support Sistemic through access to innovative and advanced measurement and analytical technologies offered by a partnership with LGC. The outcome of this project will facilitate the safe clinical progress of PSC-derived cell therapy products to bring them to a clinical product more quickly. This will in turn result in patients getting quicker access to these novel therapies during clinical trial development phases, and ultimately, to a successfully launched clinical product and therefore improvements in quality of life.

New foodstuffs or food components may, beyond their nutritional value, benefit human health, as with nutraceuticals or functional foods, or may present health risk through contamination at source or during processing. Therefore, there is need to complement chemical analysis of foods with biological screening that assesses health risk or benefit using predictive, easy-to-use tools which are standardisable across test materials and locations. The project will develop a novel system for food safety and health-benefit testing, based on screening for biological responses to food components in human cell-based systems. Analytical power will lie in the use of human primary cells with physiological relevance, in methods for pre-screening complex samples, and in the generation of high-content information using leading-edge molecular technology. The project output will be a transferable service capable of installation in food-based CRO operations and a panel of products enabling out-licensed or third party technology uptake.