For production of different monoclonal antibodies (mAbs), biopharmaceutical companies often use related upstream and downstream manufacturing processes. Such platforms are typically characterized regarding influence of upstream and downstream process (DSP) parameters on critical quality attributes (CQAs).
Host Cell Proteins (HCP) are critical quality attributes (CQAs) and must be monitored during the manufacturing processes. Typically it is analyzed by immunoassay methods (e.g., HCP-ELISA). The capacity of the immunoassay to detect a broad range of HCPs, relevant for the individual mAb-production process should be proven by orthogonal proteomic methods such as 2D gel electrophoresis or mass spectrometry (MS). In particular MS has become a valuable tool to identify and quantify HCP in complex mixtures. Protagen Protein Services (PPS) developed an approach for qualitative and quantitative control of HCPs applying shotgun LC-MS. This approach enables us to gain knowledge about HCP level, clusters and species and allows for risk assessment in HCP control.
In this webinar, experts from PPS discussed the USP and DSP parameters of four different biopharmaceutical products, two different process variants, and one mock fermentation on the HCP pattern by shotgun LC-MS analysis.