Enzyme-linked immunosorbent assays (ELISAs) are critical to detecting and removing host cell proteins (HCPs), a primary source of impurities in biologics development. Scientists must validate HCP ELISAs to ensure patient safety and meet regulatory guidelines – but different coverage assays come with different challenges, limitations, and benefits. The US Pharmacopeia recommends 2D differential gel electrophoresis (DIGE) combined with Western blot or immunoaffinity approaches, and labs might not be able to gain the full benefits of DIGE without significantly altering current…