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.

How does ELISA compare to HCP analysis by Mass Spectrometry (LC-MS)?

As wi...

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.

How does ELISA compare to HCP analysis by Mass Spectrometry (LC-MS)?

As with an ELISA, LC-MS provides you with the total HCP content (ng HCP/mg DS) in each sample. But with LC-MS you also get the ID and quantity of each individual HCP. And it is fast – just 8-12 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.

If no commercial ELISA HCP assay exists 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 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, and 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 on how the method can be applied to your samples and expression system.

Have a look at the various host cell protein analysis services below. You are welcome to contact us or watch one of our 30-minute webinars for more information.

 

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    How can HCP levels be measured throughout purification steps?

    <>Why do ELISAs give different results?

    Different HCP ELISAs detect different HCPs because they depend on the specificity of the polyclonal HCP antibodies used.

    How do you identify small host cell proteins?

    Mass spectrometry methods based on trypsin digestion, HPLC separation of the peptides, and MS/MS peptide analysis are good for for identification of small HCPs.

    How can I get label-free quantification and reproducibility of HCP data?

    SWATH® analysis results in very reproducible data – both for identification and quantification of HCPs.

    How can you qualify a Host Cell Protein assay using mass spectrometry?

    The ELISA-MS method provides both the coverage percent and also the identity of each Host Cell Protein.

    Who is this for?

    We primarily help customers within the pharmaceutical industry, and biotechs working on drug development, e.g.

    Project managers

    Working with process development and characterization projects.

    Analytical experts

    Protein scientists that work with ELISA, masss spectrometry, or CMC.

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