Introducing BL21(DE3) Host Cell Protein ELISA Kit

Recombinant expression in BL21(DE3) E. coli is a relatively simple and cost-effective method for production of certain recombinant proteins. Many of these products are intended for use as therapeutic agents in humans and animals, and as such, must be highly purified. The manufacturing and purification process of these products leaves the potential for contamination by host cell proteins (HCPs) from BL21(DE3) E. coli strain. Such contamination can reduce the efficacy of the therapeutic agent and result in adverse toxic or immunological reactions and thus it is a regulatory requirement to reduce HCP impurities to the lowest levels practical.

This simple to use, highly sensitive, objective, and semi-quantitative ELISA is a powerful 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 essentially all of the HCPs that could contaminate the product independent of the purification process. The kit is based on a broadly reactive anti-BL21(DE3) HCP Antibody detecting over 90% HCPs as determined by Antibody Affinity Extraction and Mass Spectrometry. This new Cygnus Technologies’ BL(DE3) HCP ELISA Kit provides the specificity and sensitivity (LOD ~0.4 ng/ml, LLOQ ~3 ng/ml) to detect HCPs with reproducibility that supports regulatory compliance, aiding in optimal purification process development, process control, routine quality control, and product release testing. In addition, the new BL21(DE3) HCP Control Set, F1060-C, is designed to serve as a control for the F1060 BL21(DE3) HCP ELISA Kit. It should be utilized with the F1060 BL21(DE3) HCP ELISA Kit and its associated protocol. It can also be used to trend the performance of the assay over time.