Bacterial endotoxin detection: lipopolysaccharides quantification

Limulus Amebocyte Lysate (LAL) is the regulatory reference method recommended by the pharmacopoeia for the quantification of endotoxins. However, in many cases, with complex samples or matrices for examples, interferences can occur and lead to false positive or false negative results. The Low Endotoxin Recovery (LER) phenomenon is an important issue, that both pharmaceutical companies and regulatory authorities need to deal with. For that purpose, LPS-BioSciences develops a new LC-MS² method combined to complementary analyses for endotoxin detection. This endotoxin test avoids all interferences and is able to detect endotoxins in complex matrices on the contrary of other quantification methods like LAL or MAT. The analysis provided can support the validation of your product regulatory file. 

Our LC-MS2 endotoxins quantification method enables to quantify LPS in various biological environment. This chemical quantification allows to detect endotoxins regardless of their conformation or their bacterial origin. Because each endotoxin being unique in term of structure, the detected markers can give information about their nature. 

Endotoxins are present everywhere and often lurk in our work environment. In that way, LPS-BioSciences can provide you guidance for industrial process development. We intervene on site for the implementation of technical solutions or simply do a process review. Each step of the process is reviewed to provide you with a consulting report with all key recommendations and alternatives.