This kit is designed and produced to measure the impurities of E. coli host cell proteins in recombinant pharmaceutical products in the E. coli expression system.
This kit is used to check for the presence or absence as well as the amount of E. coli host cell protein in the pharmaceutical products produced in this cell, such as recombinant drugs and vaccines. It is based on the ELISA sandwich method, which is a technique based on Ag-Ab interaction and based on the binding strength of the specific antibody of the kit (coated on the bottom of the plate) and the E. coli cell protein in the drug (sample), the color intensity produced after The binding of HRP-conjugated antibodies will be different for each sample, so it is indicating the amount of protein in the product. After comparing the OD values obtained in the experiment for pharmaceutical samples with specified concentrations of standard samples (available in the kit), the amount of host cell protein concentration in the product obtained, and by analyzing the kit Limit of detection (LOD), manufacturers could decide whether or not the product is permissible for entering the market.
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