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 Mass Spectrometry (LC-MS)?

As with an ELISA, LC-MS provides ...

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 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. 

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 – 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 and contact us for more information – or watch one of our webinars.

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    How can HCP levels be measured throughout the purification steps?

    With SWATH LC-MS analysis you can get information about specific HCPs and their quantity. It is then easy to analyze the effect of various purification processes and optimize them to avoid most, and specific, HCPs.

    Why do ELISA Host Cell Protein assays give different results?

    Different HCP ELISAs detect different Host Cell Proteins (HCPs). This is because an ELISA HCP depends on the specificity of the polyclonal HCP antibodies used. To get the perfect polyclonal HCP antibodies for detection of all HCPs you depend on a “lucky goat”. That is, a goat with the perfect antibody response against all the specific HCPs in your samples.

    Is there a way to identify small host cell proteins?

    There are some good mass spectrometry methods for identification and analysis of HCPs. The methods are based on trypsin digestion, HPLC separation of the peptides, and MS/MS peptide analysis for identification of the proteins.

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

    SWATH® analysis is a data-independent acquisition method that results in very reproducible mass spectrometry data – both for identification and quantification of HCPs. Standard proteins are added in known amounts and are digested within the sample. Robust microflow rates avoid time-consuming nanoflow HPLC and carry-over.

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

    For many years, 2D Western Blots have been used to determine the HCP ELISA coverage. However, this method is not very precise. The new ELISA-MS method, provides both the coverage percent along with the identity of each Host Cell Protein in the sample.

    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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