A multicenter comparison study between the Endosafe® PTS™ rapid-release testing system and traditional methods for detecting endotoxin in cell-therapy products

BackgroundRapid-release testing reduces the waiting period for administration of time-sensitive cell-therapy products. Current assay systems are labor intensive and time consuming. The Endosafe® portable test system (PTS™) is a chromogenic Limulus amebocyte lysate (LAL) portable endotoxin detection system that provides quantitative results in approximately 15 min. To evaluate Endosafe® performance with cell-therapy products, side-by-side testing of traditional LAL systems and the Endosafe® system was conducted at the Production Assistance for Cellular Therapies (PACT) facilities and the National Institutes of Health's Department of Transfusion Medicine, USA.MethodsCharles River Laboratories provided each center with a PTS™ reader and two commercially prepared lyophilized reference standard endotoxin (RSE) vials. All samples tested with the Endosafe® system used 0.05–5.0 endotoxin unit/mL (EU/mL) sensitivity cartridges provided by Charles River. Each vial was reconstituted with LAL water and tested in trip...