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Endotoxin Removal

Endotoxins are lipopolysaccharides (LPS) found in the cell walls of certain microorganisms, most notably gram-negative bacteria including Streptococcus and E. coli. These harmful substances, when introduced into the human bloodstream, can trigger T cell activation and the release of inflammatory cytokines, leading to severe physiological reactions, including life-threatening septic shock.

Strict regulatory limits are imposed on the levels of endotoxins in IV therapeutic products, mandating that the endotoxin load does not exceed 5 EU per kg of adult weight per hour. This requirement poses a significant challenge, especially for biopharmaceuticals derived from bacteria like E. coli. In response, we at Astrea Bioseparations have developed a comprehensive range of products designed specifically to address and solve endotoxin removal challenges. 

Our Solutions

Endotoxin removal using EtoxiClear®
EtoxiClear® is a PuraBead®-based affinity adsorbent crafted by our team at Astrea Bioseparations to effectively capture and remove endotoxins from diverse feed streams. Its active component binds specifically to the core glycolipid of endotoxins, ensuring minimal interference with biotherapeutics such as proteins and viral vectors, as well as buffer components. This selectivity makes EtoxiClear® exceptionally efficient for endotoxin removal via flow-through chromatography. EtoxiClear® delivers robust endotoxin binding with 3-4 log removal based on the initial load and maintains high protein recoveries of over 90%, irrespective of protein pI. It also features an extraordinary endotoxin binding capacity, greater than 1 million EU per ml. Additionally, EtoxiClear® boasts complete alkali stability, supporting cleaning and depyrogenation processes with 1M NaOH. It also provides high flow rates, low back pressures, and extended operational life. Available in various pre-packed column sizes and slurry packs, EtoxiClear® is indispensable for selective endotoxin removal and is suitable for both R&D and biomanufacturing applications. 

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Endotoxin removal with PuraBead® anion exchangers

The core glycolipid portion of bacterial endotoxin features negatively charged phosphate groups, making it susceptible to capture and removal through anion exchange chromatography using DEAE or Q PuraBead® resins. Although endotoxins bind efficiently to these anion exchange resins, unlike EtoxiClear®, the recovery of proteins is significantly influenced by the buffer pH and the protein's isoelectric point. All PuraBead® ion-exchange resins are designed for ease of cleaning and are fully alkali-stable. They are near-monodisperse chromatographic adsorbents that provide high binding capacities, high flow rates, low back pressures, and extended operational lifetimes. 

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