Applications

Immuno-Oncology - Gene and Immunotherapy

Chimeric antigen receptor (CAR) T-cell immunotherapy is a rapidly growing personalized treatment which expands native cellular products ex vivo for re-infusion into patients. This therapeutic approach turns the immune system’s cancer-fighting cells into better defenders by either increasing their fighting ability or their numbers. However, the construct and vector used sometimes necessitates custom assay design for immunogenicity assessment of humoral or cellular-type responses.

Analytical methods applicable to CAR T-Cell Therapy development for assessing transduction, persistence & cytokine response syndrome:

• Multi-color flow cytometry for lymphocyte differentiation, and analysis of intracellular biomarkers (i.e., cytokines)
• CAR T-cell detection and quantification by flow cytometry in PBMCs
• Enzyme-linked Immunospot (ELISPOT) analysis for characterizing specific T- or B-cell responses.
• Functional assays, and intracellular cytokine detection by flow cytometry
• Measurement of gene expressions performed by quantitative polymerase chain reaction (qPCR).
• Immunoassays (ELISA, MSD, Luminex) to measure cytokines and potential ADAs
  
  

Cancer Vaccines

Immuno modulation with cancer vaccines is another powerful therapeutic development that shows potential as both a standalone treatment and in combination with other immunotherapies.  As with other ITs, the clinical assessments for cancer vaccines include toxicological testing(especially immunogenicity and immune monitoring for safety and efficacy).  Our experts can provide assay development and testing solutions for these clinical evaluation needs.