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 provide you with the total HCP content (ng HCP/mg DS) in each sample.

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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 provide you with the total HCP content (ng HCP/mg DS) in each sample.

You also get the ID and quantity of each individual HCP. All of this in 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 the HCP-antibody coverage. And if no commercial ELISA exists for your host cell line, mass spectrometry is the perfect 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 attend one of our webinars:

Coverage analysis – Which HCPs is your ELISA missing? >>
Strategies for impurity analysis of Biologics >>
Impurity analysis for data-driven Process development >>
Impurity analysis using Mass Spec (method) >>

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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 ELISAs give different results?

Different HCP ELISAs detect different Host Cell Proteins (HCPs). This is because an ELISA HCP assay 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 of HCPs. The methods are based on trypsin digestion, HPLC separation of the peptides, and MS/MS peptide analysis for identification of the proteins.

What can I do to improve label-free quantification and reproducibility of data?

SWATH® analysis is a data-independent acquisition method that results in very reproducible MS 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.

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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