Expression systems used in the generation of biopharmaceuticals (often called biologics or biologicals) contain many proteins. The presence of residual host cell proteins (HCPs) is a potential safety risk in any biopharmaceutical product. Any residual HCP have to be removed during product purification.
The rapid growth in production of biologics has generated an expanding requirement for identification and evaluation of residual HCP. The most common method for screening biopharmaceutical products and testing for HCP is enzyme-linked immunosorbent assay (ELISA), a sensitive assay with a low detection limit, high level of reproducibility, and compatibility with high-throughput screening.
Our HCP ELISA kits are useful in both process development and process validation. Using these kits in the earliest phase of product development can provide relevant and specific data directing process improvement and decreasing the levels of HCP contamination. In quality control applications, subject to thorough validation and qualification by each laboratory, these kits may also be useful for lot release testing.
Since every process is unique, no single antibody works well for all processes. In order to increase antibody coverage, we have recently launched a new line of generic HCP ELISA kits for CHO and E.coli cells that give you access to multiple antibodies, allowing you to choose the one that works best for your process.