Novel imaging-based platform for cell quality and identity control

The National Institute of General Medical Sciences awarded Epitune LLC $350,000 on September 16, 2025, under the Biomedical Research and Research Training program (CFDA 93.859) to develop an imaging-based platform for single-cell analysis of human-induced pluripotent stem cell identity.

The platform combines microscopic imaging of epigenetic landscape, advanced image analysis, picowell arrays, and fluidic devices to enable rapid, affordable assessment of hiPSC identity at single-cell resolution. The approach addresses limitations in existing cell identity tests, which either rely on bulk analysis that obscures cell-to-cell variability or employ expensive, time-intensive single-cell techniques unsuitable for routine manufacturing quality control. The resulting platform is intended to deliver higher resolution, lower per-sample cost, and shorter turnaround time than currently available solutions. The technology is designed to be customizable for single-cell identity testing of other cell types, including blood cells, neurons, and cardiomyocytes.

Work is performed in San Diego, California, with a period of performance from September 16, 2025, through February 28, 2026.

Abstract

Cell-based manufacturing and therapies, including those using human-induced pluripotent stem cells (hipscs), require careful maintenance and tight control of the identity of cells in the culture. The existing inexpensive cell identity tests typically rely on bulk analysis that does not reveal cell-to-cell variability or the potential presence of distinct subpopulations. On the other hand, single-cell analysis techniques tend to be expensive and complex and require a long turnaround time, often prohibiting routine monitoring of cell identity. The goal of this project is to develop an affordable platform for rapid analysis of hipscs identity on a single-cell level. The proposed platform is based on the technologies of microscopic imaging of epigenetic landscape with advanced image analysis, picowell arrays, and fluidic devices that have been recently developed by a team of investigators. The successful completion of the proposed project will result in a new platform for imaging-based single-cell analysis of the identity of hipcss with a high resolution, lower cost per sample, and a much shorter turnaround time as compared with the solutions currently available on the market. With some customization, the proposed platform will also be applicable to single-cell identity tests of many other types of cells, e.g., blood cells, neurons, cardiomyocytes, etc., further enhancing the value of the proposed development.