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Endotoxin contamination, primarily from lipopolysaccharides (LPS) of Gram-negative bacteria like E. coli, poses significant risks in pharmaceutical and medical device manufacturing. Even trace amounts can trigger severe immune reactions, emphasizing the need for accurate endotoxin detection.
Evolution of Endotoxin Detection
Endotoxin detection has evolved significantly, from the Rabbit Pyrogen Test to the Limulus Amebocyte Lysate (LAL) assay and the Recombinant Factor C (rFC) assay. While LAL, derived from horseshoe crab blood, is sensitive and widely used, concerns over animal welfare and variability have prompted the development of alternatives.
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