Scientists manufacturing biological drugs (biologics), such as monoclonal antibodies or therapeutic proteins, must ensure that they removed all cell culture-related impurities, including host cell proteins (HCPs), from their samples. To do this, they perform ELISAs with specialized polyclonal antibodies, but must first determine the assay’s sensitivity to cell line-specific HCPs by doing a coverage analysis on cells that don’t express the biologic. However, when the original cell line is unavailable, coverage analysis becomes complicated because the biologic’s high concentration masks a subset of HCPs.
Watch this webinar from Cytiva to learn
- How the presence of a biologic alters coverage analysis
- How to perform coverage analysis when a control cell line is unavailable
- How to clear a biologic from a sample to improve coverage analysis