Endotoxins, also known as lipopolysaccharides (LPS), are a common contaminant found in biologically active substances. These molecules form part of the outer membrane of Gram-negative bacteria, such as E. coli, and are released during cell lysis, which happens frequently in the production of recombinant proteins. Notably, many waterborne and fecal bacteria also release LPS, leading to contamination in gloves, laboratory equipment, buffers, and downstream products like cell culture media or purified substances.
The presence of endotoxins in pharmaceuticals, particularly in biologics like biosimilars and recombinant proteins, can lead to serious adverse effects in host organisms. These include fever, chills, low blood pressure, respiratory distress, disseminated intravascular coagulation, and even fatal toxic or endotoxin shock. Hence, endotoxin detection is a critical quality control measure mandated by the FDA for drug formulations.
Endotoxin removal is crucial across various industries, including pharmaceuticals, cosmetics, agriculture, food, and biomedical research. It's especially vital in applications involving live cells, where even sterilization procedures might not suffice to eliminate these contaminants. In medical devices and implants, particularly those in contact with cerebrospinal fluid, the FDA mandates adherence to the strictest endotoxin standards.
Biotechnological processes, whether upstream or downstream, must account for endotoxin risks. From cell engineering and transfection protocols to culture media for recombinant protein production, and even in purified samples and animal experiments, ensuring endotoxin-free conditions is paramount. Misinterpretation of results in endotoxin-sensitive assays is another concern.
Various methods exist for endotoxin removal, including organic solvent extraction, ultrafiltration, ion-exchange chromatography, and affinity matrices like polymyxin B or polylysine. Each technique has its limitations, depending on the compound's properties, stability, and intended use. A combination approach, such as using cation and anion exchangers sequentially, often yields better results.
Norgen offers effective endotoxin removal kits tailored for DNA and protein samples. Their DNA kits reduce endotoxins to levels below 0.1 EU/µg, ensuring optimal transfection efficiency. For proteins, peptides, and antibodies, the ToxinEraser Endotoxin Removal System employs a modified polymyxin B matrix with a high binding capacity, achieving endotoxin levels as low as 0.1 EU/mL with minimal sample loss.
Detection methods like the ToxinSensor Endotoxin Detection System employ the FDA-approved LAL (Limulus Amebocyte Lysate) assay, offering both quantitative chromogenic kits and qualitative gel clot tests. These kits are designed for rapid, sensitive, and reliable endotoxin assessments in pharmaceuticals, biological products, and medical devices.
Accessories such as endotoxin-free pipette tips, tubes, and regeneration buffers further support contamination-free workflows. Low-endotoxin bovine serum albumin and other reagents are available for specialized applications.
For more information or assistance, feel free to reach out to our team. Understanding and managing endotoxin contamination is essential for maintaining product integrity and patient safety across diverse scientific and medical fields.
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