Do you want to optimize your bioprocess for host cell protein profile?
We identify host cell proteins in your process samples using an optimized SWATH LC MS analysis workflow. The analysis provides both identity and quantity of each individual HCP. In addition, you get the total HCP content [ng HCP/mg drug substance]. The results can then help you in your bioprocess optimization with regards to process related impurities.
You can use our services to:
- Evaluate the clearance of HCPs between purification steps to optimize purification parameters.
- Compare HCP profiles for tech-transfer batches between CMOs.
- Monitor HCP content during process changes and upscale.
Our method is based on intensive development work in collaboration with many of our biopharma clients, MS instrument vendors, and leading protein research groups. It has let to an optimized workflow providing reproducible identification and quantification of HCP.
The analysis includes:
- First, we prepare a generic sample preparation protocol for process samples in different matrices.
- A robust microflow HPLC is then coupled online to the highly advanced Sciex TrippleTOF 6600 mass spectrometer.
- Next, we perform a SWATH LC-MS reproducible identification and quantification of process related impurities / HCP. What is SWATH? >>
- Finally, we provide you with a list of Host Cell Proteins with physiochemical properties (Mw, pI, AA sequence, database accession number) for each process sample.
Send us a description of your project and we will be glad to discuss Host Cell Protein analysis with you.