To meet the demands of increasingly complex medicinal products, technologies like mass spectrometry are needed – also in a QC lab. However, for methods like MAM by LC-MS and HCP by MS little experience on how to handle mass spectrometry in a QC lab is currently available. Emerging new technologies (currently used during characterisation of new therapeutic drug modalities) as release testing methods are discussed in this session.
Session Speakers: Regulatory Considerations for the Application of Multi-attribute Method by Mass Spectrometry for QC Release and Stability Testing of Biopharmaceuticals Annick Gervais, representing EFPIA, Belgium
A Status Report from the MAM Implementation Phase Alexander Buettner, Roche Diagnostics GmbH, Germany
A Roadmap to Get Host Cell Protein Analysis by Mass Spectrometry in a GMP Environment Cyrille Chéry, UCB Pharma SA, Belgium
Novel HCP Analysis and Characterisation Tools Provide Freedom of Operation for Efficient Process Development Brian Kåre Kristensen, Novo Nordisk A/SA, Denmark