Bacterial endotoxin detection: lipopolysaccharide 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 developed 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 unlike other quantification methods like LAL or MAT. The analysis provided can support the validation of your product regulatory file. Additionally, our LC-MS² method enables precise measurement of LPS across diverse biological environments, identifying endotoxins regardless of their conformation or bacterial origin. Each endotoxin’s unique structural profile can be discerned, offering valuable insights into its specific nature.

All regulatory tests around the world: LAL, rFC, MAT, rCR are calibrated using the same standard product. In the 1970s, a Reference Standard Endotoxin (RSE) was developed from the lipopolysaccharide of a specific E. coli strain. This RSE serves as the benchmark for calibrating all LAL tests. However, RSE can be quite costly.
As a more economical alternative, Control Standard Endotoxin (CSE) is often used. It is calibrated against RSE, and can be produced using various bacterial strains.

It’s a popular choice among companies due to its cost-effectiveness and efficiency for the extensive number of endotoxin tests needed to validate products. Depending on the type of contaminants you’re looking for, you can create a customized standard to validate your test.

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.