Why You Should Not Rely On Western Blotting For HCP Antibody Coverage

For years, 2D Western blotting has been the traditional method for assessing Host Cell Protein (HCP) antibody coverage, yet its technical limitations often create a false sense of security. The manual nature of the process, combined with low sensitivity and a limited dynamic range, frequently results in an underestimation of the actual impurities present in a sample. When a drug substance is present, it can physically mask the very proteins the assay is intended to detect, leading to data that fails to meet the rigorous demands of modern regulatory scrutiny.

Transitioning to more sensitive, objective methodologies is no longer just an advantage—it is a necessity for ensuring therapeutic safety. By moving toward advanced enrichment techniques, manufacturers can achieve a much more accurate representation of antibody reactivity. Understanding the pitfalls of legacy methods is the first step in de-risking your purification process. To learn why traditional blotting may be failing your analytical strategy and to discover superior alternatives for coverage analysis, read the full technical article.