Cell Therapy Immunogenicity Testing

High-throughput Screening for the Presence of Anti-Drug Antibodies (ADAs)

Create high-throughput custom assays designed to detect ADAs

Chimeric Antigen Receptor (CAR)-T cell therapy is an innovative cancer treatment that utilizes and redirects the cytotoxic capabilities of T cells to target cancer cells. This therapy involves engineering T cells to express a chimeric antigen receptor, which combines an antibody targeting a specific cancer cell marker with TCR signaling components. Several CAR-T cell therapies have been approved for treating hematological malignancies, with numerous clinical trials underway exploring their potential across a wide range of diseases. Given the significant investment in this promising therapeutic approach, it is crucial to develop robust analytical strategies to accurately assess their safety and efficacy.

Immunogenicity, the ability of a biotherapeutic to trigger an immune response, is a critical factor influencing its safety and efficacy. When a biotherapeutic is introduced into a patient, the immune system may perceive it as foreign and mount an immune response against it. For CAR-T therapies, the CAR construct on the T cell surface can be recognized as foreign, making it essential to implement clinical assays that monitor this potential immune reaction.

The immune response has two primary components: humoral and cellular. The humoral response is mediated by B cells, which generate antibodies against the therapeutic, referred to as anti-drug antibodies (ADAs). In the case of CAR-T therapy, a humoral immune response would involve the production of ADAs targeting the recombinant CAR. These ADAs can be identified using a custom PhIP-seq assay (library) which would include sufficient overlapping peptide inserts that would allow not only high-level immunogenicity to be identified, but it would also identify the specific area of the CAR that has elicited the response.

Our unique CRO services provide the experience and expertise necessary to develop high-throughput, cost-effective custom assays that help detect immune responses to CAR constructs. Our innovative approach ensures accurate identification of immune reactions, enabling researchers to advance their studies with confidence and efficiency.