In recent years, we have learned that host cell proteins (HCP) can cause problems with respect to patient safety, drug substance (DS) stability, and DS efficacy. As such, it is more important than ever to fully understand the HCPs in your process.
This webcast will focus on using advanced methods of immunoaffinity chromatography and mass spectrometry to fully characterize the host cell protein ELISA as well as the individual HCPs of in-process and DS samples.
- Review of coverage analysis methods demonstrates that coverage percentage depends on a method used to assess it.
- Why Antibody Affinity Extraction combined with Mass Spectrometry (AAE-MS™) is the most sensitive and specific assessment method.
- How AAE-MS provides in-depth characterization of HCPs present in DS.
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