Development of a High-Throughput Cryoprotection Screening Platform for Cell Therapies

Abstract

Type 1 Diabetes is a devastating disease in which the immune system attacks insulin-producing beta cells in the pancreas, disrupting the normal blood glucose regulation mechanism and resulting in damage to major organ systems. An emerging therapy for Type 1 includes transplanting stem cell-derived beta cell aggregates into patients, restoring normal regulation of blood glucose and eliminating the need for insulin injections. Reliable cryopreservation methods are required to meet global demand for these aggregates, but current protocols result in low cell viability post thaw and require complex post processing to remove the toxic cryopreservation agent (CPA) formulation before implantation. In this work, a high-throughput screening method is developed to identify a novel non-toxic CPA formulation that would enable the scale-up of this new Type 1 Diabetes treatment. The development and validation of workflow steps are presented, in addition to data from pilot experiments that execute all workflow steps.