A Fit-for-Purpose Approach to Monitor Viability and Biomarker Stability of Human Tumor Infiltrating Leukocytes

CYTO 2021 -- With the progress in drug development for cancer immunotherapy, a comprehensive evaluation and scoring of solid tumors resected from patients will allow for optimization and selection of most beneficial therapies and provide insights for personalized medicine. Single-cell based platforms using flow cytometry have been instrumental to address these questions and to reveal the composition of immune subsets infiltrated into the tumor tissues. The integrity of flow cytometry data largely depends on the quality of tumor specimens to be processed into single cell suspensions. Here, objectives were to validate optimal conditions for the storage and shipping of the fresh tumor resection to preserve the integrity of biological specimen for further functional investigation to support drug development. We have developed a fit-for-purpose approach to monitor viability, and establish stability and precision parameters to qualify proprietary processes and two high-parameter cytometry assays to support cellular and protein biomarker investigation and discovery in tumor infiltrating leukocytes.