For new biologics under development, validated HCP impurity assays are needed for the GMP release test to show product purity.
However, it has been challenging to move HCP analysis by LC-MS into QC laboratories due to the complexity of the sample preparation and data analysis, the sophistication of the high-end mass spectrometers, and the lack of reproducibility of the complete workflow.
This year’s BEBPA HCP conference is addressing the issue in two talks and a round-table discussion:
• Host Cell Proteins – Passing Regulatory Hurdles.
Presented by Erika Friedl, Quality Expert, Paul-Ehrlich-Inst.
• Moving LC-MS HCP Analysis into a GMP Environment.
Presented by Thomas Kofoed, CEO, Alphalyse A/S