This case study discusses the Low Endotoxin Recovery (LER) phenomenon in the drug testing and mitigation approach using the ENDO-RS® kit and ENDOLISA® assay for detecting endotoxin interference
Since Chen and Vinther first described a unique drug formulation phenomenon that renders the detection of endotoxin using Limulus-based methods ineffective, the debate has raged as to how the phenomenon should best be mitigated. The phenomenon was labelled “Low Endotoxin Recovery” or LER. It should be noted that LER can be complicated by the presence of protein masking owing to the differential of the isoelectric points of endotoxin and many proteins
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