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Expression of viral vectors and vaccines in Vero cells is a cost-effective method for production of commercial quantities of a drug substance. The manufacturing and purification process of these products leaves the potential for impurities by HCPs from Vero cells. Such impurities can reduce the efficacy of the therapeutic or vaccine agent and result in adverse toxic or immunological reactions. Thus, it is desirable to reduce HCP impurities to the lowest levels practical. This kit was developed using the antibodies that have been generated against and affinity purified using mild lysate of Vero cells. This simple to use, robust, and semi-quantitative ELISA is a sensitive and specific method to aid in optimal purification process development, process control, routine quality control, and product release testing. This kit is “generic” in the sense that it is intended to react with a majority of the HCPs that could pollute the product independent of the purification process. This Vero Cell HCP ELISA has an LOD of ~1.4 ng/ml. Please use Sample Diluent, Item No. I028, with these kits; available separately.
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