Eurofins BPT Italy offers single cell analysis for process and product characterisation

Nicolo Sacchetti, Science and Business Manager, Eurofins Cell & Gene, nicolo.sacchetti@bpt.eurofinseu.com; Giulia Mancini, Bioassay Laboratory Manager, Eurofins BioPharma Product Testing Italy, giulia.mancini@bpt.eurofinseu.com; Stefano Baila, Managing Director Support Biologics , Eurofins Cell & Gene, stefano.baila@bpt.eurofinseu.com

Cell-based immunotherapies consist of cells that are manipulated, and often gene modified, providing the capacity to treat diseases like tumors. These therapies are composed of a heterogeneous population of cells, both phenotypically and functionally, in which not all the cells have the same effectiveness in targeting and treating the disease.

The characterisation of cell-based immunotherapies today primarily relies on bulk analytical tests, which typically overlook the inherent heterogeneity of these products. As a result, the ability to predict the in-vitro potency of these therapies remains a significant unmet need.

Single-cell technologies offer the potential to perform a deeper characterisation of immunotherapies, providing critical insights for the cell therapy industry as it seeks to understand the roles of the diverse cell populations that comprise therapeutic batches.

Thanks to the collaboration with Cellply, Eurofins BioPharma Product Testing Italy can now offer the VivaCyte technology, a single-cell analytical tool that delivers reproducible phenotypical and functional characterisation at a single cell level using minimal amounts of valuable product samples. This cutting-edge solution allows a deeper understanding of the complexity that underlies heterogenous immune cell therapy candidates, offering an insight of their potency and persistence. The high throughput of single cell data that VivaCyte can analyze also enables the generation of a novel Unified Killing Score (UKS). This innovative approach combines the single cell granularity of this analysis with an easily interpretable score that facilitates direct comparisons between immune cell samples (e.g. from different donors or different gene edits), or across different cell therapy batches.

Identifying the ideal starting material cells and/or the most effective manufacturing processes, which feature higher serial killing activity and better kinetics, can enable the development of more potent products capable of generating a therapeutic response in the patient.

Eurofins BioPharma Product Testing Italy can offer clients comprehensive single-cell functional characterisation services for cell-based immunotherapies to improve and save lives. For more information visit: www.eurofins.it/biopharma/comprehensive-cell-and-gene-therapy-testing-capabilities/