What’s Really Behind Endotoxin Detection Failures? A New Study Offers Clues
Pharmaceutical safety depends on reliably detecting lipopolysaccharide (LPS) contamination using the Limulus Amebocyte Lysate (LAL) assay. However, a phenomenon known as Low Endotoxin Recovery (LER) can cause known endotoxin levels to go undetected - posing a challenge for quality control.
A new study by AstraZeneca and the University of Manchester, conducted at Diamond using dynamic light scattering (DLS) and small-angle X-ray scattering (SAXS), investigates why LER occurs. The researchers examined how common formulation ingredients - chelating agents, surfactants, and divalent cations - affect the size and shape of LPS aggregates.
Their findings challenge long-standing assumptions and suggest that the mechanisms behind LER may be more complex than previously thought.
The study opens new avenues for research and quality control in pharmaceutical development.
Read the paper to discover what the data reveals.