Evaluation of PBMC processing in the Precision Bioservices laboratory network (HUM7P.325)

Abstract

Cryopreservation of peripheral blood mononuclear cells (PBMC) is a good alternative to testing fresh PBMC in clinical trials as functional immunologic assays may be batched to increase efficiency. Functional assays are essential for accurately evaluating the performance of vaccines, antiviral and anticancer agents. Optimal retention of PBMC functionality during cryopreservation depends on optimized and standardized cell isolation, freezing and storage conditions. Collection and analysis of PBMC is a significant technical challenge in multi-center clinical trials due to pre-analytical variability in processing, freezing and storage. It is vital that all centers participating in a multi-center collaboration operate with consistent protocols. To this end, Precision has developed a Laboratory Network (PLN) to ensure quality PBMC processing across multi-center trials. The current study was performed within the PLN to ensure samples processed at each laboratory achieved similar results. We report the recovery, viability and functionality of PBMC obtained from participating laboratories. Phenotypic characterization of the major cell subset was also analyzed and the percent obtained was comparable across laboratories. This data provides confidence that PBMC processing in a multi-center clinical trial operating with the same standard operating procedures (SOPs) produces comparable data, thus accelerating drug and vaccine development.