Host Cell Proteins Detection (CAT#: STEM-MB-0140-WXH)

Introduction

Host cell proteins are impurity proteins produced by cell secretion, stress, lysis and purification processes during the production of recombinant proteins, antibodies, vaccines and other biological drugs using cultured host cells. Residual HCPs in drugs may be immunogenic and affect drug quality, safety, and efficacy. Therefore, it is necessary to establish a suitable method to detect residual HCPs and optimize the purification process to remove them in the downstream purification process or to achieve a controllable low enough level.
Traditional methods used to detect HCP include convective immunoelectrophoresis (CIE), sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE), western blotting, two-dimensional gel electrophoresis, multiple assay enzyme-linked immunosorbent assay (ELISA) and high performance liquid chromatography (HPLC), etc. Sandwich ELISA is currently the most commonly used method for HCP analysis. HCP quantification mainly relies on the number and affinity of anti-HCP antibodies to detect HCP antigens.