Testing of Bacterial Endotoxin in Recombinant Human Coagulation Factor

It is reported that most of the patients with hemophilia A have been treated with factor Ⅷ. At present, there are manufacturers on the market that extract factor VIII and recombinant factor VIII produced from plasma. Due to the limitation of raw material plasma, the production of plasma-derived factor Ⅷ is very limited, and imported recombinant factor Ⅷ is expensive, and generally cannot be afforded by patients with hemophilia. In the production of recombinant human factor VIII, the establishment of quality control methods is also imminent. Among them, the establishment of bacterial endotoxin detection methods is very important for controlling the pyrogenicity of products. Therefore, a method for rapid detection of bacterial endotoxins must be established.

Maximum effective dilution of test product (MVD)

Recombinant human coagulation factor Ⅷ stock solution, semi-finished products and finished products were diluted with bacterial endotoxin test water at different multiples, and each dilution multiple was simultaneously tested for endotoxin recovery. The dilution multiple with a recovery rate close to 100% was determined as the best dilution of the sample multiple. The sensitivity of the krypton reagent in the dynamic turbidity method is 0.03 EU/mL (the low point of the standard curve), so the effective dilution factor is MVD = L/λb = 5/0.03=166 times.

kinetics turbidity method

The kinetics turbidity method is a reaction of factor C of endotoxin and limulus reagent. The activated coagulase cuts the arginine peptide chain in the coagulogen protein to form a coagulated protein. The turbidity changes in the process of generating gel. The turbidity meter detects the reaction time required for the turbidity of the reaction mixture to reach a predetermined absorbance, or the method for detecting the turbidity increasing rate. This method has high sensitivity, simple operation and wide detection range.

Our Services for endotoxin testing in recombinant human coagulation factor

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:

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Project name Endotoxin testing in recombinant human coagulation factor
Testing purpose In the production of recombinant human factor VIII, the establishment of quality control methods is also imminent. Among them, the establishment of bacterial endotoxin detection method is very important to control the pyrogenicity of products. Therefore, a method for rapid detection of bacterial endotoxins must be established.
Testing cycle 3-5 days.
Service including We provide you with raw data and test reports.
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