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

Abstract

Background-Rapid 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 which provides quantitative results in approximately 15 minutes. To evaluate Endosafe ® performance, specifically 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

Determination of ATP-activity as a useful tool for monitoring microbial load in aqueous humidifier samples

“…Furthermore, according to the manufacturer, the rapid endotoxin test requires laboratory equipment, which negates the aim of having a method that could be rapidly used to measure microbial load in the field. In accordance with our study Gee et al (2008) found no significant difference between traditional and rapid LAL test regarding endotoxin activity of 178 samples from cell therapy products However, they pointed out as well that it is a major limitation of the test that only one dilution at a time is measurable. In conclusion based on our study, it is not reasonable to suggest the rapid test Endosafe for the analysis of humidifier water directly in the field.…”

“…Methods without culturing are for example DNA sequencing (Nonnenmann et al, 2010), fluorescence analysis using DAPI staining (Klug and Jäckel, 2012), measurement of endotoxin activity with the LAL test (Gee et al, 2008;Liebers et al, 2009), detection of pyrogenic activity with whole blood assay (Liebers et al, 2010;Punsmann et al, 2013), determination of fungi antigen or ␤-glucan by the ELISA technique (Sander et al, 2008(Sander et al, , 2012Zahradnik et al, 2013), and ATP content via bioluminescence (Hammes et al, 2010;Mueller et al, 2009;Liebers et al, 2012).…”

Evidence for the detection of non-endotoxin pyrogens by the whole blood monocyte activation test

“…A recombinant Bet (based on a genetically engineered protein from the Carcinoscorpius clotting cascade), which does not consume any animals, has been developed and validated to some extent (Ding and Ho, 2001;loverock et al, 2010). Special lAl-techniques have been developed for testing very small sample volumes (Jimenez et al, 2010;Gee et al, 2008).…”

Production of Clinical Grade Mesenchymal Stromal Cells

“…The problem with this test is not the time (results can be usually obtained in 3-4 hours), but its sensitivity to external factors and complexity of its setting. Endosafe® PTSTM is a chromogenic LAL test that provides quantitative results in approximately 15 minutes (Gee et al, 2008). It has been already validated for testing of bone marrow mononuclear cells for cardiac regeneration (Soncin et al, 2009), and is relatively easy to use.…”