Development of characterisation and potency assays for immunotherapy products

Fabian Vandermeers
Sandra Thys
Thomas Henri
Mike Collodoro (PDC*LINE PHARMA)
Arnaud Delobel

In recent years, cell-based immunotherapy has become a great interest for pharmaceutical companies, particularly because of its promise to treat various forms of cancer. Cell-based immunotherapy aims to treat patients by stimulating their immune system using autologous or allogeneic cells. It is based on a targeted immune response against specific tumor antigen(s) leading to the destruction of malignant cells. Among these promising therapies, chimeric antigen receptor T cells (CAR-T), antigen-pulsed dendritic cells (DC) and natural killer cells (NK) are in development and are entering the different clinical phases for several indications of cancer.

Optimising the quality of these products is critical to ensure the safety and efficacy of novel cancer treatments. Release tests are therefore required by authorities in order to show satisfactory identity, safety, purity and potency.

In this study, we developed several assays to characterise and prove the biological activity of immunotherapy products:

  • phenotype determination by flow cytometry

  • cytokines production by Luminex

  • cytotoxicity and activation assay using cell-based assays