TCR-T and CAR-T/NK/MA Cell Cytokine Release Assay

Recombinant CAR cells may result in rapid and excessive release of cytokines, which can lead to cytokine release syndrome (CRS), sometimes referred to as cytokine storms. Cytokine storms can cause significant and potentially life-threatening toxicities, and patients feel very uncomfortable. Macromolecular therapeutics (e.g., vaccines, therapeutic mAbs and other biological agents) have the same risks.

Assessing the potential risk of acute or long-term immunogenicity of macromolecules is a regulatory requirement. Pre-clinical evaluation of cytokine release syndrome by peripheral blood mononuclear cells (PBMCs) is a FDA-recommended test. This active and early assessment of cell activation, proliferation, and cytokine release may help reduce the risk of adverse reactions in later clinical development.

Based on our streamlined workflow, Creative Biolabs can help provide this critical early immunogenicity assessment by testing your macromolecular biologics against our human donor PBMC library using a combination of cell proliferation and multiple cytokine/chemokine release assays. For CAR cells, we can test the immunomodulatory potential of CAR cells by assessing their ability to produce cytokines after stimulation.

Cytokine Release Assay

Cytokine

Developed in accordance with FDA recommendations for preclinical testing of biologics
Determination of 10 cytokines/chemokines: IL-2, IL-6, IL-8, IL-10, IL-1β, IL-12p40, IL-17A, IFNγ, MIP-1α and TNF-α
Choose any of our cryopreserved PBMC donors or custom tests using non-human PBMC
Appropriate controls provide air drying, wet adhesion or soluble antibody presentation methods
Incubation time is 24 or 48 hours
PBMC proliferation test on request
Additional markers can be added upon request

Cytokine Release Assay Workflow

For more details, please feel free to contact us for project quotations and more detailed information.