Analytical Characterization of Host Cell Proteins (HCPs)

Abstract

Biotechnology products such as biopharmaceuticals, including biosimilars, are produced in living organisms or cells. A common phrase that we hear is “the process is the product.” Thus, this process of producing these products in living organisms presents several unique challenges to consider. One of those key challenges is the characterization of not only the product itself, but other impurities in the form of host cell proteins (HCPs) that may be present. To ensure that these HCPs do not have clinical implications, it is important to understand what they are. Therefore, in this column, we take a closer look at specific analytical technologies and tools to analyze these host cell proteins, with a specific focus on liquid chromatography (LC) and mass spectrometry (MS) approaches.