Host Cell Protein (HCP) Immunoassays and Role of Mass Spectrometry in Identification of HCP Impurities in Downstream Samples

Register free: http://www.biopharminternational.com/bp_w/downstream_samples

Event Overview:
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 

Key Learning Objectives:

• Methods for HCP antibody coverage analysis 

• Enrichment of HCPs by immunoaffinity chromatography and identification by Mass Spec is a powerful orthogonal method to ELISA enabling full understanding of those HCPs that are present in the product and could potentially impact patient safety and drug stability 

• Incorporation of immunoaffinity chromatography and MS methods into HCP analytics early in the project ensures the best possible clinical outcome

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

Time and Date: Tuesday, Jun. 16, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

On demand available after airing until Jun. 16, 2021

Sponsor: Cygnus Technologies

Register free: http://www.biopharminternational.com/bp_w/downstream_samples