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"Best Practices In HCP Assay Qualification And Bridging To A New Assay"

Source: Cygnus Technologies Inc.

Go beyond the basics of HCP analysis and see what a truly data-driven strategy can reveal. This case study dives into a real-world HCP immunoassay, enhanced by cutting-edge orthogonal Antibody Affinity Extraction (AAE™) and Mass Spectrometry (MS) techniques for robust assay qualification.

Follow the data as it uncovers HCP profiles across every stage—from product harvest to in-process samples to final drug substance—using advanced MS identification. Along the way, Eric Bishop, Vice President of R&D at Cygnus Technologies, shares how integrating MS proteomics with ELISA and AAE creates a more complete, nuanced picture of HCP impurities.

Discover how this powerful combination of methods enables smarter, evidence-based decisions—helping determine when a process-specific assay truly adds value over a well-established generic or platform approach.

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