AAE-MS™: A Powerful Method to Assess Host Cell Protein ELISA Fit for Purpose

This webcast features: Alla Zilberman, PhD, vice president, technical marketing, Cygnus Technologies.

Antibody Affinity Extraction (AAE) is a powerful orthogonal approach to determine if a host cell protein (HCP) ELISA is fit for purpose. AAE is referenced as immunoaffinity chromatography in USP 1132 and has been used in over 300 projects to perform antibody coverage analysis for regulatory submissions.

This webinar focuses on several case studies demonstrating utility of AAE-MS method in identification of immunoreactive HCPs to establish HCP antibody coverage, HCPs enriched during process changes, and HCPs co-purified with DS.

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