Best Practices for HCP Analysis in Biopharmaceutical by Mass Spectrometry - Seguridad Mania.com - España y América Latina

Presented by Annu Uppal PHD. Director-Scientific Affairs & Strategy at USP & Anita Krishnan, Head of Analytical Sciences at Biocon Biologics Mass spectrometry has become an increasingly common approach for identification and quantitation of Host cell proteins (HCPs) to support risk assessment and process development, as well as characterization and quality control. This presentation will provide an overview of the proposed general chapter <1132.1> Residual Host Cell Protein Measurement in Biopharmaceuticals by Mass Spectrometry. The best practices for instrument selection, sample preparation, LC separation, MS data acquisition, MS data analysis and reporting, with particular attention to the orthogonality of MS and traditional methods will be discussed. Additionally, there will be an update on the development of physical reference materials to support identification and quantitation of HCPs of particular concern.