Endotoxin Testing and Removal

Endotoxin is a common contaminant found in samples containing recombinant proteins or nucleic acids purified from gram-negative bacteria such as E. coli. Endotoxins, also known as lipopolysaccharides (LPS), are heat-stable molecules associated with the outer membranes of certain gram-negative bacteria. Sub-nanogram levels of endotoxin can trigger immune responses and septic shock in mammals. Endotoxin also affects a number of cell types in tissue culture experiments. The Food and Drug Administration (FDA) has established strict guidelines for the allowable endotoxin content of injectable drugs. Given the risks of endotoxin contamination, accurate endotoxin detection and quantitation in protein/peptide samples is crucial.  Currently, LAL and recombinant Factor C assays are the main methods of endotoxin testing.  These assays rely on enzymatic reactions and are susceptible to factors that can inhibit or enhance enzymatic performance.  

Our team of experts can help you in developing endotoxin test assays and removal methods for your drug development needs. We currently offer a sample treatment kit, EndoTreat™  to enhance endotoxin detection, applicable to either LAL or rFC assays.

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Founded in 2008 through an academic research collaboration, we provide high-throughput biologics formulation services backed by proven science. Using advanced self-interaction chromatography (SIC), we rapidly screen protein stability with minimal material, delivering results in weeks—not months. With 30+ commercial projects completed, we offer end-to-end support from protein expression and formulation through analytical testing, stability studies, and Phase I manufacturing.