Lipopolysaccharide Structure and the Phenomenon of Low Endotoxin Recovery

Graphical Abstract Caption: When purified LPS is spiked, as an assay control, into an undiluted drug product which also contains chelating agent and surfactant, over time the LPS can be masked from detection by the LAL-assay, which is the gold-standard industrial LPS detection method. This raises a concern whether all LPS can be reliably detected by this assay. The mechanism of LPS masking is described as the phenomenon of Low Endotoxin Recovery (LER). To date, the true mechanism of LER remains unknown. The review provides a state-of-the-art description of ongoing LER research.