Thermo Fisher Scientific Applied Biosystems PureQuant Assays

Applied Biosystems PureQuant Assays, from Thermo Fisher Scientific, are a family of assays that identify and quantify specific immune cell types in a mixed population of cells.

Designed for in-process and release testing of cell-based therapeutics, the assays measure genomic DNA methylation at sites that are unique to a specific immune cell type. With standards and controls built into each assay, they are ready to be seamlessly integrated into cell therapy workflows.

The assays’ core technology has been used for the identification and quantification of immune cell types for more than a decade. The qPCR method is easily standardised, enabling consistent results across multiple users, instruments and sites. The assays can be performed using fresh or frozen cells/gDNA, enabling flexibility.

The assays provide an innovative method for identity and purity testing of cell-based therapeutics, supporting cell therapy research, development and manufacturing. Regulatory support file is provided upon request, with established performance specifications following ICHQ2(R1) guidelines.