Bacterial endotoxin is a type of pyrogen that comes from the outer membrane of Gram-negative bacteria. A very small amount of endotoxin enters the animal or human body will cause a strong inflammatory response, leading to severe consequences such as mild fever and severe death. The drug regulatory authorities of various countries have strict regulations on the content of endotoxin in biological products. The European Pharmacopoeia stipulates that the limit of endotoxin in injections must not exceed 5 EU/ (kg·h), EU is an endotoxin unit, and each EU is approximately 100 pg. The risk of bacterial contamination is widespread in biopharmaceutical processes. Preventing bacterial contamination and controlling endotoxin content in products are huge challenges faced by the majority of biopharmaceutical practitioners. Among biopharmaceuticals, monoclonal antibody drugs require higher endotoxin limits due to the large doses used (tens to hundreds of milligrams). Monoclonal antibodies, as a class of targeted drugs, have received great attention from the medical community for their outstanding efficacy and low adverse reactions, and the development of monoclonal antibody drugs has also been extremely active. Monoclonal antibodies, as biological macromolecular drugs, have complex production and purification processes, and many links may bring endotoxins into the production process. Therefore, the ability to effectively remove endotoxins in the purification process steps will ensure that the product meets endotoxin standards.
Endotoxin removal is one of the most difficult tasks downstream in protein purification. At Creative BioMart, our experienced scientists will develop a customized protocol for your target protein after estimating endotoxin removal efficiency and sample recovery. We will use a combination of the following methods to ensure maximum efficiency.
The hydrophobic column interacts with nonpolar protein surfaces through van der Waals forces for endotoxin removal.
It uses composite polyacrylamide as the column, which is highly porous. Ultrafiltration results in relatively good endotoxin clearance from product solutions when the products are of low molecular weight.
This method involves the separation of aqueous surfactant solution into micelle-rich and micelle-poor regions through excluded-volume interactions. External agent notably Triton X-114 is needed to maintain the inherent biological activity of the protein while reducing endotoxin level by 100-fold.
The high selectivity of affinity chromatography eliminates the need for multiple purification steps and reduces production costs. At the same time, this method can remove endotoxin with high specificity and efficiency, resulting in excellent target recovery.
Creative BioMart offers a corresponding endotoxin removal service. You can purchase the corresponding endotoxin removal kit and related accessory products according to the needs of your own samples. We guarantee that all instruments, water, reagents, and consumables used in the experiment are free of endotoxins, and the experiment is conducted in a clean room to ensure that low levels of endotoxins are returned to the sample. In addition, we can also provide you with related services including:
|Project name||Endotoxin removal services in antibodies|
|Removal cycle||5-7 days.|
|Removal purpose||Among biological drugs, monoclonal antibody drugs require higher endotoxin limits due to the use of large doses (tens to hundreds of milligrams).|
|Service including||Creative BioMart can screen for the source of endotoxin contamination in the production process and propose several solutions to remove endotoxin to reduce the endotoxin content in the finished product.|