E.coli Host Protein Residue Detection Kit (Enzyme-Linked Immunosorbent Assay · One-step Method)

Host Cell Protein (HCP) is a complex with multiple physiological, chemical and immunological properties. Its potential immunogenicity, influence on the stability and efficacy of biological drugs and toxic and side effects may have an impact on the safety and efficacy of products. Therefore, the residual content of HCP in biological products is regarded as one of the key quality attributes (CQA) of the products. The Chinese Pharmacopoeia, the United States Pharmacopoeia (USP), the European Pharmacopoeia (EP), and the ICH all point out that effective methods are needed to strictly monitor and detect residual HCP in biological products. This product uses the ELISA double antibody sandwich method to determine the content of host protein HCP in the sample.

Quality monitoring of the production process of biological drugs such as recombinant proteins, antibodies and vaccines.