How to future-proof the analysis of host cell proteins in biopharma using microflow LC-MS/MS
The increasing prevalence of new expression systems in biomanufacturing, new modalities in biotherapeutics, and new analytical technologies such as LC-MS/MS, is likely to lead regulators towards the requirement for more HCP data from biopharma manufacturers.
This article addresses the issues and proposes a new way of securing a comprehensive, 4-dimensional digital record of HCP data for potential future requirement by regulatory bodies.
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