How Well Are Your HCP ELISAs Covered?

By Joe Hirano, Program manager, Imaging

Coverage assays provide a means to validate the enzyme-linked immunosorbent assays (ELISAs) used in host cell protein (HCP) quantitation. They enable you to estimate the percentage of HCPs that can be detected, or ‘covered’, by ELISA, and direct you towards filling any gap. The goal is to develop processes for reducing HCPs, improving drug efficacy and patient safety, and meeting regulatory guidelines. These ELISAs and coverage assays are an essential part of process development in biologics manufacture, and can have an impact on the potential success of a drug.

Here, I’ll take you through the strengths and weaknesses of one of the most common types of coverage assay, and outline an approach that retains its best traits while enhancing speed and accuracy.