Host cell protein analysis
Our aim is to provide you with the best protein analysis service by providing access to our service-minded team of highly experienced and skilled scientists, hand-picked from leading universities and companies. Together, they cover most fields of protein chemistry, mass spectrometry and bioinformatics. They also apply top-of-the-line equipment and are experts in interpretation of its data for biopharmaceutical protein characterization.
Services
ELISA characterization and
HCP coverage analysis
Data for risk
assessment
Monitoring specific
process-related impurities
Documentation of the
manufacturing process
Residual protein analysis of
complex products
Data for regulatory
documentation
Identification and quantitation of Host Cell Protein in biologics
Alphalyse probably offers the most detailed Host Cell Protein analysis available. 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 a host cell protein assay by Mass Spectrometry (MS)?
MS analysis provides the total HCP content (ng HCP/mg DS) in each sample as with an ELISA. But MS analysis goes beyond this and also gets the ID and quantity of each Host Cell Protein. And it is fast – just 4-8 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 analysis 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 in public databases or in 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 in our videos, you will find examples of how other clients have used our host cell protein analysis.
FAQ
MS-based HCP analysis gives information about specific HCPs and their quantity – to analyze the effect of various purification steps
Different HCP ELISAs detect different HCPs. That is because they depend on the specificity of the polyclonal HCP antibodies used.
You can use mass spectrometry methods based on trypsin digestion, HPLC separation of the peptides, and MS/MS peptide analysis
The ELISA-MS method provides both the coverage percent and also the identity of each Host Cell Protein. Use it to qualify your HCP ELISA.
Talk to us
Whatever protein-related challenge or question you may have, we would love to help. Our experts can help you decide on the best analytical approach for your project by email or online meeting - providing advice without obligation.