Host Protein Residue Detection: Key to Biopharmaceuticals

Host cell protein (HCP) residual detection refers to the testing of proteins that may remain in the final product and originate from the production cell line (i.e., the "host") during the biopharmaceutical production process. This testing is crucial because these host cell proteins (HCPs) may impact the safety, efficacy, and quality of drug products.

 

In the fields of biotechnology and biopharmaceuticals, commonly used drugs such as monoclonal antibodies and other recombinant proteins are often produced in cell culture systems, such as E. coli, CHO (Chinese Hamster Ovary) cells, or yeast cells, etc. Proteins from these host cells can mix with the target product, so it is necessary to identify and quantify them through HCP residual detection.

 

Enzyme-Linked Immunosorbent Assay (ELISA)

This is a commonly used method that detects HCPs by using antibodies against host cell proteins. Although ELISA is very sensitive, its specificity may be limited because not all HCPs will be detected.

 

Western Blotting

This method can be used to detect specific host proteins and determine their relative levels in samples.

 

Mass Spectrometry

Mass spectrometry is a powerful technique for identifying and quantifying proteins in mixtures, including any possible HCPs. Compared with ELISA and Western blotting, it offers higher specificity and coverage.

 

Multiplex Immunoassay Techniques

For example, using platforms based on multiple antibodies, multiple HCPs can be detected simultaneously.

 

When conducting host cell protein (HCP) residual detection, it is essential to consider the specific host system used for the production of bioproducts, as different host systems may generate different HCPs. Additionally, the detection strategy must be sufficiently sensitive to meet the stringent requirements of regulatory agencies regarding HCP levels, thereby ensuring the safety and efficacy of the final product.