Endotoxin Testing in Vaccine

A vaccine is a biological agent that provides active acquired immunity against a specific infectious disease. Vaccines often contain agents similar to pathogenic microorganisms, usually made from weakened or killed microorganisms, their toxins or one of their surface proteins. The substance stimulates the body's immune system, recognizes it as a threat, destroys it, and further identifies and destroys any microorganisms it may encounter in the future. Vaccines can be prophylactic (preventing or mitigating the effects of future infections by natural or "wild" pathogens) or therapeutic (eg, anti-cancer vaccines being studied). The administration of the vaccine is called vaccination. Vaccination is the most effective way to prevent infectious diseases; bacterial endotoxin must be detected before vaccination, otherwise it will cause serious consequences. Bacterial endotoxin test is widely used in the medical industry, mainly to check whether the bacterial endotoxin in the drug meets the relevant standards. Bacterial endotoxin test consists of two methods: photometry and gel. Mainly through the compatibility test between the drug and the reagent, and then the interference test on the test product and the verification of the results of the interference test, etc., and then check the bacterial endotoxin in the test product, so as to achieve the inspection of toxin content.

Vaccine.Fig1. Vaccine.

Method

Creative BioMart uses Limulus Amebocyte Lysate test for vaccine 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 test.Fig2. Workflow of limulus Amebocyte Lysate test.

Our Services for endotoxin testing in vaccine

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 vaccine
Testing purpose Bacterial endotoxins must be tested before vaccination, otherwise it will cause serious consequences. Bacterial endotoxin testing is widely used in the medical industry and is mainly used to check whether bacterial endotoxins in drugs meet relevant standards.
Testing cycle 3-5 days.
Service including We provide you with raw data and test reports.
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