February 15, 2018

Exotoxin Clearance from mAb Samples in a Two-Step Chromatography Process

endotoxinA heat-stable exotoxin can remain as a contaminant of a drug substance throughout the whole manufacturing process, with the risk of adversely affecting patients’ health. One such toxin is cereulide secreted by Bacillus cereus, a ubiquitous spore former that is of concern during the manufacture of pharmaceuticals. 

This work demonstrates the clearance of cereulide from monoclonal antibodies (mAbs) produced in Chinese hamster ovary (CHO) cells over two purification steps.

Read more in this application note.


Tags: antibodies, chromatography, Mab, bioburden control, exotoxin