Endotoxin

Endotoxins are part of the outer membrane of the cell wall of Gram-negative bacteria. As such they can potentially contaminate cell cultures during production of biopharmaceuticals or contaminate final therapeutic products. At BioOutsource we can provide testing of raw materials and process intermediates through to the final product for release testing to ensure that these materials are endotoxin-free.

We perform a LAL (Limulus Amebocyte Lysate) test with a standard kit utilizing a Chromogenic End-Point method in accordance with the harmonised USP <85> Bacterial Endotoxins Test and EP <2.6.14> Bacterial Endotoxins Test. Limulus Amebocyte Lysate is an aqueous extract of blood cells from the horseshoe crab Limulus polyphemus. In the presence of endotoxin, factors in LAL are activated in a proteolytic cascade that results in the release of a chromogenic peptide which can be measured by spectrophotometry.

The kit methodology can be qualified for use with the client’s test material to ensure reliable results. Assay runs are completed within a working day and allow for fast turnaround times. Our standard reporting timeline for endotoxin testing is two weeks from the first assay to provision of COA.

Contact our biosafety experts to discuss your endotoxin testing requirements.