Monitoring for contaminants is a critical step during the production process in the pharmaceutical and medical device industries. A frequent contaminant, endotoxin, can cause fever, inflammation, headache, nausea, and even death. Found in the cell wall of gram-negative bacteria, endotoxin has routinely been detected by the sensitive and specific Limulus Amebocyte Lysate (LAL) assay. In the presence of endotoxins, LAL coagulates through an enzyme-mediated cascade, which has then been traditionally quantified based on gelation and turbidity.
This application note demonstrates the suitability of the SpectraMax® Mini reader and LAL Kinetic- QCL Assay in endotoxin quantitation.
This application note discusses: