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Residual endotoxin is one of the possible causes of the host immune response. Endotoxin may be introduced during the production of viral vectors, either in the plasmid DNA required, in the transfected HEK 293T cells, or in the production environment. Creative Biogene has developed sensitive, accurate and rapid tests for the timely detection of endotoxin in the production of GMP viral vectors, ensuring safe and reliable products for our clients.
The release of endotoxin is caused by bacterial death autolysis or adhesion to other cells, and also occurs during normal cell growth and division. During viral vector preparation, there are two main sources of endotoxin contamination: bacterial endotoxin and environmental endotoxin. Endotoxins are toxic to the host, and even small amounts of endotoxins may induce an immune response. Endotoxins can bind to receptors on cell membranes to induce an immune response, activate the release of inflammatory cells and inflammatory factors in tissues, have a strong toxic effect on cells, and affect the growth and function of cells in vivo and ex vivo. In the in vivo environment, endotoxin acting on mammals can lead to fever in the organism and trigger a systemic inflammatory response, followed by disseminated intravascular coagulation, shock, multi-organ functional attenuation, and ultimately death. Therefore, we need to remove as much endotoxin from the vector as possible, both for experimental studies involving viral vectors and for clinical applications.
According to the regulatory requirements of drug production, endotoxin determination based on horseshoe crab reagents is the gold standard for the detection of endotoxin residues. Creative Biogene offers different LAL-based assays, including gel assays, dynamic turbidimetric assays, dynamic colorimetric assays, and recombinant factor C assays. We help you choose the most suitable LAL assay to help you with any questions regarding endotoxin detection.
The gel method is a horseshoe crab test method that applies the principle that horseshoe crab reagents can agglutinate with endotoxin to detect endotoxin qualitatively or semi-quantitatively, and the horseshoe crab reagents must be used after re-solubilization with exothermic raw water (water for endotoxin examination) during the test, and the end point of detection is determined by observing the presence or absence of gel formation. The gel method is easy and economical to operate, and does not require the use of special testing equipment.
Quantitative assay of endotoxin. The turbidity method is a horseshoe crab test method that detects the endotoxin content by measuring the change in turbidity during the reaction between the horseshoe crab reagent and endotoxin, where the dynamic turbidity method detects the time required for the turbidity of the reaction mixture to rise to a predetermined absorbance or the rate of turbidity increase.
Quantitative assay of endotoxin. The chromogenic substrate method is a horseshoe crab test method that detects the amount of endotoxin content by detecting the amount of coagulase produced during the reaction between the horseshoe crab reagent and endotoxin to make the specific substrate free born chromophore, and calculates the level of endotoxin based on the chromaticity of the product, also known as the colorimetric method.
Sustainably synthesized alternative to LAL assays based on the recombinantly produced form of Factor C, the first component in the horseshoe crab clotting cascade.
As a trusted partner, at Creative Biogene you can find many tools to improve the efficiency of your viral vector quality control testing procedures. Please contact us for more information about the endotoxin assays. We will be happy to assist you.
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