Identification of Host Cell Protein (HCP) Impurities using Antibody Affinity Extraction and Mass Spectrometry Approach

This webcast features: Eric Bishop, Vice President of Research & Development, Cygnus Technologies

A well-developed, broadly reactive, and qualified HCP ELISA remains a gold standard method effectively used during the purification process to ensure removal of HCP and to demonstrate process consistency and final drug substance purity. Unfortunately, the ELISA does not inform which HCPs are present or to which HCPs the assay reacts.

Mass Spectrometry (MS) is a powerful tool for identifying those HCPs that persist through downstream purification processes. One of the limitations of MS in identifying HCPs in the final drug substance (DS), is that DS often mask HCPs. To improve MS sensitivity, Antibody Affinity Extraction™ (AAE™) can be used as a sample preparation method to enrich HCPs and eliminate most of the DS in a sample. When combined with AAE, Mass Spectrometry can also be used to assess antibody coverage to HCPs in a given process and identify those HCPs that are reactive with the antibody.

In this webinar, we will discuss:

  • How AAE and MS proteomics methods can be integrated with ELISA and AAE for a comprehensive characterization of HCP impurities
  • When to use MS during process development and in clinical and commercial manufacturing
  • Cygnus AAE-MS Services

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