Host Cell Protein Analysis
Identification and quantitation of Host Cell Protein in biologics
Alphalyse probably offers the most detailed Host Cell Protein analysis available on the market. Where most other suppliers provide analysis based on ELISA kits or antibodies, we use advanced SWATH® mass spectrometry to analyze ho...
Alphalyse probably offers the most detailed Host Cell Protein analysis available on the market. Where most other suppliers provide analysis based on ELISA kits or antibodies, we use advanced SWATH® mass spectrometry to analyze host cell proteins.
How does ELISA compare to an analysis by Mass Spectrometry (MS)?
As with an ELISA, MS analysis provides you with the total HCP content (ng HCP/mg DS) in each sample. But MS analysis also gets the ID and quantity of each Host Cell Protein. And it is fast – just 4-12 weeks – without needing a null-cell line.
Additionally, if you already use ELISA kits or antibodies, we can help you measure their HCP-antibody coverage.
Is there no commercial ELISA HCP assay available for your host cell line? Mass spectrometry is the solution for detecting and measuring host cell proteins and other process-related impurities.
The HCP MS analysis applies to all types of samples and expression systems:
The approach can be applied to all process samples, from harvest to final drug product. It applies to all expression systems, including E. coli, CHO, yeast, HEK, adenovirus, etc. The only requirement is that the host cell proteome be sequenced and available. Either in public databases or your possession.
Please send us a request to start a dialogue. We would love to show you how the method can be applied to your project.
You are also recommended to watch one of our 30-minute webinars for more information. And on our video page, you will find examples of how other clients have used our host cell protein analysis.