In-depth cell therapy product characterization remains central to the successful development of safe and efficacious cell therapies. Regulatory agencies require release testing to confirm the identity, purity, potency and safety of cell-based products. Thermo Fisher Scientific now offers novel, robust and reproducible identity and purity assays for CD8+ cells, regulatory T cells (Treg) and T helper cells (Th17) that are ready to be implemented in cell therapy manufacturing.
The Applied Biosystems PureQuant Assays provide an alternative to flow cytometry to accurately identify and quantify CD8+ T cells, Tregs and Th17 cells in a mixed population. These new TaqMan® qPCR-based assay kits measure genomic DNA methylation at specific sites that serve as a unique cell type specific identifier. Assays include all reagents, standards and controls.
- Facilitates regulatory filings—shorten development timelines; established performance specifications following ICHQ2(R1) guidelines
- Proven technology—used for immune cell identification and quantification for over a decade
- Easily standardized—helps enable consistent results across multiple users, instruments, and sites
- Scheduling flexibility—run fresh cells, frozen cells or gDNA at your convenience
Comparison of PureQuant Treg Assay and flow cytometry
Figure 1. PureQuant Treg Assay compared to flow cytometry for highly purified Treg populations derived from three different donors.
Invitrogen eBioscience Essential Phenotyping Kits
The Invitrogen eBioscience Essential Phenotyping Kits are designed for flow cytometry–based identity testing of T cells, Tregs, and Th1/Th17 cells. These turnkey kits leverage high-quality eBioscience antibodies, isotype controls and reagents (when applicable) and include a ready-to-use protocol for experimental set up and analysis.
- Proven performance—antibodies and supporting reagents developed specifically for flow cytometry
- Highly referenced antibodies—kits include the most referenced clones for FOXP3 and IL-17
- Turnkey kit and protocol—kits contain reagents and standardized gating needed to perform flow cytometry characterization
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