Choosing The Right Sample For HCP Antibody Coverage Analysis

A critical phase in qualifying a Host Cell Protein (HCP) ELISA is demonstrating that the polyclonal antibody has broad reactivity across the diverse array of proteins present in a specific manufacturing process. However, the accuracy of this coverage analysis depends entirely on the starting material. Choosing between a null cell culture harvest and a product-containing sample is not just a matter of availability; it dictates which analytical methodologies will yield valid results.

Understanding when to pivot to advanced techniques like Antibody Affinity Extraction (AAE) combined with Mass Spectrometry is essential for identifying the persistent HCPs that pose the greatest risk to patient safety. To ensure your coverage analysis is truly representative and meets evolving regulatory expectations, explore the full article for a deep dive into sample selection strategies and orthogonal method integration.