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Bacteria pyrogen such as endotoxins, also called lipopolysaccharides (LPS), are major contaminants found in commercially available proteins or biologically active substances. This bacterial endotoxin is a potent stimulator of the mammalian immune system in vivo, and it may decrease tissue culture cell viability and inhibit transfection efficiency in vitro. This often complicates the study of the biological effects of the main ingredient. Even low levels of endotoxins can be toxic to cells or organisms and must be removed
before biological samples can be introduced.
Bio-Synthesis understands that a reliable and accurate endotoxin test result and removal for your biological sample is extremely important for downstream applications. Our extensive experience in depyrogenation of endotoxin removal from protein/peptides, antibodies, and oligonucleotides,assures that your endotoxin-free preparation will be ready for in vivo or cell culture studies in a timely manner. Whether it is method development for new product lines or routine endotoxin testing analysis, let us help you confidently deliver a safe and reliable product to the ones you serve.
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Endotoxins, also called lipopolysaccharides (LPS), are major contaminants found in commercially available proteins or biologically active substances. This bacterial endotoxin is a potent stimulator of the mammalian immune system in vivo, and it may decrease tissue culture cell viability and inhibit transfection efficiency in
vitro. This often complicates the study of the biological effects of the main ingredient
by causing false readings in cell-based assays, or it can cause side effects in host organisms such as endotoxin shock, tissue injury, and even death. Current FDA limits require eluates from medical devices to be less than 0.5 EU/mL, unless the device comes into contact with cerebrospinal fluid where the limit is then 0.06 EU/mL. Due to these reactions, it is essential to remove endotoxins from drugs, injectables, and other biological and pharmaceutical products.
Endotoxin testing is necessary for the following:
During the early days, one of the first tests used to determine if endotoxins were present was the Rabbit Pyrogen Test (RPT). A rabbit was inoculated with the test substance and then monitored it to see if a fever was induced. This test however,
does not give a quantitative result, is time consuming, and is not suitable for products that may in themselves adversely affect the animal.
The most commonly used approach now is a Limulus Amoebocyte Lysate or LAL test.The LAL test focuses in particular on 2-keto-3-deoxyoctonoic acid, and it is this which is used as an indicator in the majority of endotoxin assays.
LAL is a reagent derived from the blood cells of the horseshoe crab. Unlike a mammal, the crab does not have a developed immune system. However, the LAL component in its blood will bind to and inactivate endotoxins. In the crab, the resulting clot alsoforms a protective barrier against bacterial infection. At its simplest, the LAL
test consists of adding LAL reagent to the sample in a test tube if a gel or clothas formed. Then a positive result is recorded.
Bio‑Synthesis offers rapid endotoxin testing solutions which ensures to our customers the safety and quality of their products.
Qualitative analysis of endotoxin: $175/test
Quantitative analysis of endotoxin: $225-$350/test (price vary based on sample type)
To help us better understand your project, please complete our Endotoxin Sample Testing Information Sheet. The more we understand your project needs, the more accurate feedback we will be able to provide you.
Bacterial endotoxins (lipopolysaccharides, LPS) show strong biological effects in human, animal and cell cultures even at very low concentrations. Due to the high toxicity of bacterial endotoxins and DNA in vivo and in vitro, the removal of pyrogen from pharmaceutical products, recombinant proteins produced in E. Coli(or other gram-negative bacteria), and tissue culture media is of great importance for many applications.
Bio-Synthesis's Endotoxin Removal Kits are designed based on spin-column chromatography using Bio-Synthesis's innovative resin as the separation matrix. The sample can be easily purified from contaminating endotoxins within 20 minutes with a
recovery rate of >90%. Depending on the sample types, endotoxin levels are reduced to less than 0.1 EU to 0.01 EU/µg of DNA or protein.