Removal of endotoxin from monoclonal antibodies using Vivapure centrifugal ion exchange membrane devices

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Introduction

Endotoxins are lipo poly saccharides present in the cell wall of most Gram-negative bacteria, and are frequently present as contaminants in protein solutions purified in research environments. Endotoxins haveprofound biological effects at low concentrations and thus they require removal prior to use of such preparations in biological cell-based assays.The term EU is used to describe the activity of endotoxins, and typically the limit for endotoxin is set at 50 EU/mg for bioactive proteins destined for cell-based assays; limits may be lower for more demanding in vivo applications. Achieving this low level is often a challenge in biological research as endotoxins are robust molecules surviving extremes of temperature and pH that would normally denature proteins. Thus, it isoften difficult to remove endotoxins from sensitive substances such as antibodies.

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