Do you want to optimize your bioprocess for host cell protein profile?
Mass spectrometry is a great tool for optimizing your bioprocess. We identify and quantify individual host cell proteins in your process samples using top-of-the-line mass spectrometry technology no matter the complexity or purity of the sample.
You can also use our services to evaluate the clearance of individual and total HCP at different purification steps. To optimize your bioprocess; purification parameters can be compared to find the right conditions for an optimal HCP profile.
Our method is based on an in-solution digestion followed by LC MS/MS peptide analysis. We use the highly advanced Sciex TrippleTOF 6600 mass spectrometer using SWATH technology. We search the obtained MS data against an ion library of host cell proteins. The library will match your specific cell line and it includes your drug substance sequence.
The analysis includes:
- Identification of HCPs in each process batch.
- Comparison of HCPs in various process batches.
- In-solution trypsin digestion and SWATH LC-MS/MS.
- Complete list of HCPs with physiochemical properties (Mw, pI, AA sequence, database accession number).
Both the FDA and EMA are increasingly aware of mass spectrometry (MS) as an orthogonal method to ELISA. We can also help you identify HCPs in pre-clinical and clinical batches.