TOYOPEARL NH2-750F: Flow-through Removal of Endotoxin

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Endotoxins are remnants of bacterial cell walls that may contaminate drug products and cause an immunogenic response. They are often referred to as “pyrogens” due to their fever-inducing effects. Endotoxins may be found in drug products either due to contamination from host cells used to produce a drug product in a bacterial expression system or due to adventitious bacterial contamination in non-microbial products. Thus, endotoxin clearance is a requirement of downstream processing of biologics, especially those derived from microbial expression systems that contain endogenous host cell endotoxin. In this study, we evaluate the ability of TOYOPEARL NH2-750F for the removal of endotoxins by anion exchange chromatography.

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