Endotoxin Testing in DNA Vaccine

DNA vaccine, also known as "naked" DNA vaccine, genetic vaccine, also has DNA vaccine vaccine (DNA vaccine immunizaiton), polynucleotide vaccine (poly nucleotide vaccine) and other related names, it is a new research field derived from gene therapy research in recent years. DNA vaccines have potential advantages over conventional vaccines, including the ability to induce a wider range of immune responses. Several DNA vaccines are available to veterinarians. Currently, no DNA vaccine has been approved for human use. Researchers are working on ways to target human viral, bacterial and parasitic diseases, as well as multiple cancers. The DNA vaccine is the third-generation vaccine. They contain DNA encoding pathogen-specific proteins (antigens). DNA is injected into the body and absorbed by cells, and the cells' normal metabolic processes synthesize proteins based on the genetic code in the plasmids they absorb. Because these proteins contain regions characteristic of the amino acid sequence of bacteria or viruses, they are recognized as foreign substances, and when they are processed by host cells and displayed on their surfaces, they alert the immune system and then trigger an immune response.

DNA vaccine and Gene therapy techniques are similar.Fig1. DNA vaccine and Gene therapy techniques are similar.

Why should we detect endotoxin in DNA vaccine?

The standard for bacterial endotoxin residue in plasmid DNA products for gene therapy is less than 1EUPkg body weight or less than 011EUPLg plasmid. Animal experiments have shown that plasmid DNA that does not meet this standard can cause toxic reactions by intramuscular injection of mice and guinea pigs. The reagent method has been used for the testing of endotoxins in many pharmaceutical products, but for the new vaccine form of DNA vaccine It is necessary to establish corresponding testing methods to determine whether DNA itself will interfere with plutonium reagents.


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 testing and quantification of bacterial endotoxins.In Asia, a similar Tachypleus amebocyte lysate (TAL) test based on the local horseshoe crabs Tachypleus gigas or Tachypleus tridentatus is occasionally used instead. The recombinant factor C (rFC) assay is a replacement of LAL/TAL based on a similar reaction. 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.The LAL cascade is also triggered by (1,3)-β-D-glucan, via a different Factor G. Both bacterial endotoxins and (1,3)-β-D-glucan are considered pathogen-associated molecular patterns, or PAMPs, substances which elicit inflammatory responses in mammals.

Our Services for endotoxin testing in DNA 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 DNA vaccine
Testing purpose Animal experiments show that plasmid DNA that does not meet this standard can cause toxic reactions by intramuscular injection of mice and guinea pigs. Therefore, plasmid DNA must pass endotoxin detection.
Testing cycle 3-5 days.
Service including We provide you with raw data and test reports.
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