Development of innovative technology for inactivation of endotoxins at low temperature condition utilizing gas phase sterilization system

Background & Aim With the rapid development of gene and cell therapy, it is increasingly important to address the continuing risk concerns of endotoxins involving in the manufacturing and quality control of medical products and devices. Although dry-heat sterilization is generally considered as the preferred method for rendering heat-stable materials free of endotoxin, there are limitations to the effective approaches available to inactivate bacterial endotoxin, especially at low temperature. We have developed innovative technology as gas phase sterilization system based on a catalytic reaction mechanism by use of methanol to generate mixed biogas, exhibiting remarkable performance of nucleic acid decomposition as well as sterilization. Here we will present our recent challenge of findings of additional remarkable function of this system exhibiting inactivation of bacterial endotoxin at even low temperature around room temperature. Methods, Results & Conclusion Standard endotoxin indicators 2,000 EU/vial (2K-ET) (Charles River Laboratores, CRL) were used for the experiments, and endotoxin concentrations were determined by Endosafe®-PTS™ instrument including disposable PTS™ cartridge FDA (0.05-5 EU/mL) (CRL). 2K-ET vial was directory exposed to mixed biogas in apparatus for 60 min at 37 or 60 degree celsius, and endotoxin concentrations were measured using 2K-ET samples dissolved in 1mL endotoxin-free water. After biogas exposure for 60 min., endotoxin concentration levels showed remarkably reduction up to 6∼11 %, and those effects suggested to be temperature dependent; 83.3±4.7 EU/mL at 37 degree, 46.0±0.85 EU/mL at 60 degree, control sample (non-exposure): 725±23.5 EU/mL. Thus, this innovative gas phase sterilization system could exhibit valuable potential as practical performance of endotoxin inactivation at low temperature as 37 degree. Although it is still necessary to develop the reduction performance into 3-Log reduction, this advantageous function is expected to be widely useful and have high potential in the public health and pharmaceutical industries in the future.