SistemPSCCheckTM

Introducing SistemPSCCheck™, our high sensitivity, QC and batch release assay to support the clinical development of pluripotent stem cell-derived cell therapy products

A microRNA-based assay for the detection of residual, pluripotent stem cells in derived cell therapy products

Introduction

Cell-based therapies have great potential in many medical conditions. As the stem cell therapy sector develops, pluripotent stem cells (PSCs), particularly induced pluripotent stem cells (iPSCs), are becoming an increasingly popular way of producing derived cell therapy treatments.

However, residual PSCs remaining in the final derived cell therapy product can potentially form tumours.

Until now, there has been no simple established way to assess the level of residual PSCs in derived cell preparations. In particular, there has so far been no simple and rapid commercial assay platform suitable for routine QC testing and batch release.

This unmet need within the stem cell therapy sector is now addressed by SistemPSCCheck™

SistemPSCCheck™ assay overview

The SistemPSCCheck™ assay comprises a PSC-specific miRNA panel and an internal miRNA control. The assay determines the number of residual PSCs in derived cell preparations. The PSC source can be either embryonic stem cells (ESCs) or iPSCs, and the derived cell source can be any differentiated cell type.

The assay has been thoroughly validated according to ICH guidelines.

The SistemPSCCheck™ assay is a service product provided by Sistemic, whereby cellular samples are sent to Sistemic by the customer and data, in the form of a QC batch release Material Safety Sheet, is returned to the customer.

The SistemPSCCheck™ assay demonstrates exceptional detection sensitivity, being able to consistently detect residual levels of ≤ 0.0005% with 100% diagnostic accuracy.

If you would like to receive further information regarding the assay or our Early Access Programme, contact us at info@sistemic.co.uk.