T Cell Potency Assay

Cell-based immunotherapies offer powerful cures to cancers that were traditionally considered to be a death sentence. However, these medicines are significantly more complex than small molecule pharmaceuticals, or even biologics. As a result, R&D, manufacturing, and QC testing require fundamentally different analytical methods to measure essential quality attributes such as identity, safety, specificity, and potency.

Bulk measurements of cell populations are incapable of quantifying the potency of highly heterogeneous and dynamic cell-based medicines. Similarly, single time-point measurements will inevitably miss important events and functions in dynamic living medicines. Live cell assays in CloneDwell plates enable statistically meaningful sample sizes at single-cell resolution for complete characterization of critical quality parameters for release or for testing during development.

The Celldom CloneXplorer and consumables provide a flexible combination of assays to comprehensively characterize cell mixtures using a single platform, rather than requiring a piecemeal of partial assays and instruments (e.g., flow cytometry, live imaging, supernatant ELISA):

• Potency – percentage of cells that kill

• Viability – percentage of live cells

• Functionality – secretome patterns in each cell

• Identity – surface markers (e.g. CAR)

• Purity – presence of contaminants

• Specificity – on-target vs. off-target

• Persistence – cells that kill and then expand