HCP antibody coverage analysis
A required step for HCP ELISA qualification
To monitor the effectiveness and consistency of downstream purification processes, biomanufacturers rely on Host Cell Protein ELISA. A well developed and qualified HCP ELISA will provide your team with confidence that a purification process performs consistently across batches and reduces HCPs to safe levels. A factor that distinguishes HCP ELISAs is their requirement of HCP-antibody coverage assessment to ensure broad reactivity to an array of HCPs in a manufacturing process. Regulatory agencies require use of orthogonal methods to demonstrate antibody coverage to individual, process-specific HCPs to support use of a particular HCP immunoassay.
Generate meaningful results with Antibody Affinity Extraction™
Cygnus Technologies’ Antibody Affinity Extraction (AAE™) is an advanced orthogonal method designed to assess polyclonal antibody coverage for an array of HCPs that are present in a given biomanufacturing process and for downstream-process–specific HCPs that could copurify with drug substances. Developed in 2013 and used in hundreds of HCP Antibody Coverage Analysis projects, this method overcomes analytical deficiencies of antiquated two-dimensional western blot (2D WB) and two-dimensional differential in-blot electrophoresis (2D DIBE) methods.