Host Cell Proteins (HCP)

Immunoassays and Role of Mass Spectrometry in Identification of HCP Impurities

A well-developed and broadly reactive HCP ELISA remains a gold standard method effectively used during the purification process to ensure removal of HCPs and to demonstrate process consistency and final drug substance purity. Regulatory guidelines require that sponsors use orthogonal methods for demonstrating antibody coverage to individual HCPs and provide a comprehensive assay qualification package to ensure the HCP ELISA is fit for purpose. In this webcast, we will discuss:

• Advantages and limitations of HCP Immunoassays
• How immunoaffinity chromatography and mass spectrometry (MS) methods can be integrated with ELISA for a comprehensive characterization of HCP impurities
• When to use MS during process development and in clinical and commercial manufacturing

Presented by Cygnus Technologies & Biopharm International

Speaker: Eric Bishop, Vice-President, Research & Development at Cygnus Technologies