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.
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.