Endotoxin Testing in Protein

Endotoxin is a component of the cell wall of Gram-negative bacteria called lipopolysaccharide. LPS is toxic to the host. Endotoxin is only released when the bacteria die and lyse or destroy the bacterial cells by artificial methods, so it is called endotoxin. Its toxic component is mainly lipid A. Endotoxin is located on the outermost layer of the cell wall, covering the mucosin of the cell wall. The toxic effects of endotoxins of various bacteria are relatively weak, and they are about the same. They can cause fever, microcirculation disorders, endotoxin shock, and disseminated intravascular coagulation. Endotoxin is heat-resistant and stable, and its antigenicity is weak! It is generally used to make pharmaceutical proteins, such as immunoglobulins, human albumin or related products, endotoxin testing is required.

Method

Creative BioMart uses Limulus Amebocyte Lysate test for protein endotoxin detection. The primary application for LAL is the testing of blood or cerebrospinal fluid. There are three basic methodologies: gel-clot, turbidimetric, and chromogenic. The primary application for LAL is the testing of parenteral pharmaceuticals and medical devices that contact blood or cerebrospinal fluid. In the United States, the FDA has published a guideline for validation of the LAL test as an endotoxin test for such products. Limulus amebocyte lysate (LAL) is an aqueous extract of blood cells (amoebocytes) from the Atlantic horseshoe crab, Limulus polyphemus. LAL reacts with bacterial endotoxin lipopolysaccharide (LPS), which is a membrane component of gram-negative bacteria. This reaction is the basis of the LAL test, which is widely used for the detection and quantification of bacterial endotoxins.

Workflow of limulus Amebocyte Lysate testFig1. Workflow of limulus Amebocyte Lysate test.

Pyrogen testing is one of the important inspection items to ensure the safety of drugs. In 1923, Seibert first proposed the method of detecting pyrogens in rabbits. In 1942, the United States Pharmacopoeia first used the rabbit method as a pyrogen test for drugs, which played an important role in ensuring drug quality and drug safety. Rabbit pyrogen test can objectively reflect the characteristics of pyrogens in various drugs and biological products in the body, and can intuitively reflect the temperature rise of experimental rabbits caused by pyrogens in drugs.

Our Services for endotoxin testing in protein

Creative BioMart offers a corresponding endotoxin testing 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:

Our solutions

Project name Endotoxin testing in protein
Testing purpose The toxic effects of endotoxins of various bacteria are roughly the same. They can cause fever, microcirculation disorders, endotoxin shock and disseminated intravascular coagulation. Endotoxin has heat resistance and stability, and its antigenicity is very weak! It is commonly used in the manufacture of pharmaceutical proteins, such as immunoglobulins, human albumin, or related products, which require endotoxin testing.
Testing cycle 3-5 days.
Service including We provide you with raw data and test reports.
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