A cell ID assay that assists cell therapy providers in identifying their cell of interest
SistemMSCCheck™ is a novel cell identity assay that uses microRNA (miRNA) markers unique to mesenchymal stromal/stem cells (MSCs) to confirm the identity of MSC-based cell products. The assay gives cell therapy manufacturers a faster and more cost-effective way to verify that the cells they are producing are the cells they intend to produce.
MSCs are among the most widely used cell types in cell therapy and regenerative medicine, with a number of clinical trials currently registered worldwide. Confirming the identity of these cells is a critical quality control step, as manufacturers must demonstrate that their product is what they say it is before it can progress towards the clinic. Established methods for confirming cell identity, such as flow cytometry, rely on panels of surface markers and can be expensive, time-consuming and demanding in terms of equipment and expertise.
SistemMSCCheck™ takes a different approach. By detecting miRNA markers that are specific to MSCs, the assay provides a clear molecular signature of cell identity that can be read out quickly and from small sample volumes. This reduces both the time and the cost of identity testing, helping manufacturers to streamline their quality control workflows without compromising on the rigour required for cell therapy development and manufacture.
SistemMSCCheck™ joins Sistemic’s growing portfolio of cell diagnostic assays, which includes SistemPSCCheck™ for the detection of residual pluripotent stem cells in derived cell products. Together, these assays support developers and manufacturers of cell therapies in meeting the quality and safety standards expected by regulators and the wider field.
Dr. Liam Brennan, Vice President of Scientific Operations at Sistemic, stated, “Cell therapy manufacturers need confidence in the identity of their product, but they also need testing that is practical and affordable at scale. SistemMSCCheck™ was developed to meet that need, offering a faster and more cost-effective alternative to approaches such as flow cytometry while maintaining the high standards our collaborators expect from Sistemic.”
Jim Reid, Chairman and CEO, added, “Cell therapies hold real promise for conditions that have so far been very difficult to treat, but getting these products to patients depends on robust, accessible quality control. The launch of SistemMSCCheck™ reflects Sistemic’s commitment to providing the tools that the cell therapy community needs.”
SistemMSCCheck™ is available now and is soon being further rolled out for use in other cell types.
For more information, contact info@sistemic.co.uk
Sistemic Scotland Ltd
Campbell House
Central Business Park
Greenside Road
North Lanarkshire
ML1 5FL
United Kingdom
info@sistemic.co.uk