HCP-MS analysis soon available as a release assay

10 December 2021

Today, we submit our application for manufacturing authorization to the health authorities, soon enabling us to perform quality control of active pharmaceutical ingredients according to EU and US GMP.

The submission concludes a three-year investigation of our mass spectrometry-based Host Cell Protein analysis (HCP-MS) method’s robustness and reproducibility across more than 200 projects.

Common for all projects is that we used the same set of 7 standard proteins as internal standards. Therefore, we can evaluate different parameters of importance for method validation and for transferring the method to a GMP environment.

Learn more about how we qualify LC-MS analysis in this webinar >>

Update 14 March: We just received the official letter from the health authorities that we have received approval of our application, meaning that we are now able to perform HCP analysis under GMP.