Do you want to identify host cell proteins in your pre-clinical tox batch or GMP phase I/II batches?
FDA and EMA are increasingly aware of mass spectrometry (MS) as an orthogonal method to ELISA, for measuring HCP levels in a drug product. Therefore, we have developed a sensitive mass spectrometry method for identification and quantification of host cell proteins down to low ppm concentrations.
The SWATH LC-MS method provides identification and relative quantification of HCPs down to low ppm concentrations. Firstly, we digest the HCP drug product in-solution and analyse the complex peptide mixture by LC-MS/MS. Our scientists perform the analysis on a Sciex TrippleTOF 6600 instrument using data-independent SWATH data acquisition and ion library searching. As a result, the HCP analysis deliver low-to-sub-ppm detection limits and highly reproducible quantification of each HCP.
Furthermore, we also develop HCP analysis for up- and downstream bioprocess optimization.