Patients who receive cancer immunotherapy treatments in clinical trials must have their peripheral blood mononuclear cell (PBMC) samples collected at baseline and at later time points. Immune monitoring facilities provide laboratory testing of these PBMC samples in order to gauge the response of the patient’s immune system to the test treatment.
A primary focus of immune monitoring facilities is therefore to develop cutting-edge technologies whilst also standardizing and validating immune assays with rigorous quality-control standards to ensure data reliability. After all, the weight of clinical trial results depends on the accuracy, precision, and reliability of data generated from these PBMC samples.
The fragile nature of biological samples makes standardization of laboratory procedures an especially important focus. Parameters that can affect data include the anticoagulant used for preserving PBMC samples, the time frame between sampling and processing, storage/shipping temperature en route to the central processing lab, the cryopreservation and thawing process, as well as the cell culture media.[1]