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 offer analysis based on ELISA kits or ELISA antibodies, we use advanced SWATH® mass spectrometry to analyz...
Alphalyse probably offers the most detailed Host Cell Protein analysis available on the market. Where most other suppliers offer analysis based on ELISA kits or ELISA antibodies, we use advanced SWATH® mass spectrometry to analyze host cell proteins.
How does ELISA compare to 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 with MS analysis you also get the ID and quantity of each individual Host Cell Protein. And it is fast – just 4-12 weeks – and without the need for 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 avaliable for your host cell line? Mass spectrometry is the solution for detecting and measuring host cell proteins, as well as other process-related impurities.
The HCP MS analysis is applicable to all types of samples and expression systems:
The approach can be applied to all types of process samples from harvest to final drug product. It also applies to all types of expression systems, including E. coli, CHO, yeast, HEK, adenovirus, etc. The only requirement is that the host cell proteome must be sequenced and available. Either in public databases or in your possession.
Send us a request to start a dialogue. We would love to show you how the method can be applied to your project.