Advanced Characterization of HCP Polyclonal Antibodies: Combining Antibody Affinity Extraction and Mass SpectrometryAdvanced Characterization of HCP Polyclonal Antibodies: Combining Antibody Affinity Extraction and Mass Spectrometry

To monitor the effectiveness and consistency of downstream purification processes, biomanufacturers rely on HCP enzyme-linked immunosorbent assays (ELISAs). But HCP ELISAs have analytical limitations, necessitating orthogonal confirmation of their ability to detect HCPs. Qualifying an ELISA involves determining its range and demonstrating sufficient dilutional linearity, accuracy, and precision. 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. Combining AAE immunoaffinity chromatography with MS — Cygnus’s proprietary AAE-MS method — provides a powerful means for HCP-antibody coverage analysis. In addition to assessing coverage percentage, AAE-MS analysis identifies HCPs that are present in harvest material and antibody-reactive. Importantly, the AAE-MS method is currently the only approach that can assess HCP-antibody coverage reliably when the only available sample is a product (DS) containing harvest material.  The AAE-MS approach enables analysts to shift the conversation about HCP-antibody coverage assessment from a simple question — “What is the coverage percentage?” — to a more insightful one: “What specific HCPs does your HCP ELISA quantify?” Early application of tools such as the AAE-MS method helps analysts to identify HCPs that could diminish product stability, drug efficacy, and even patient safety. The better that an organization understands the HCP profile for a particular process, the higher will be the associated product’s chance of success in clinical trials and, ultimately, the market.

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