Biosimilar analysis

Detailed analysis of biosimilars and comparison to originator

How do you make sure that your biosimilar lives up to the same strict regulatory criteria as the originator product?

An effective, thorough way is to apply mass spectrometry-based methods and thus analyze aspects, such as protein sequence, intact mass, concentration, post translational modifications or process-related impurities as part of your biosimil...

How do you make sure that your biosimilar lives up to the same strict regulatory criteria as the originator product?

An effective, thorough way is to apply mass spectrometry-based methods and thus analyze aspects, such as protein sequence, intact mass, concentration, post translational modifications or process-related impurities as part of your biosimilar analysis.

For approval of originator products, a comprehensive documentation of Host Cell Proteins (HCPs) must be carried out. Even though biosimilars contain the same active product ingredient (API), analysis shows that the HCP content might not be the same. Thus, the API in biosimilars might have different activity or immunogenic ability, and should be subject to just as extensive an HCP analysis as their originators to verify that the biosimilar does not have a critical Host Cell Protein population.

What you get out of a collaboration with us

Alphalyse can analyze any protein-based biosimilar and compare it to its reference product. With detailed HCP results, you might even find that your biosimilar has a safer HCP profile. This would be a great selling point to pass on to the regulatory authorities for market approval.

With the Alphalyse HCP analysis you can intelligently optimize your process development, track the removal of residual proteins added during manufacturing, measure the HCP assay coverage and even compare HCP ELISA kits from different vendors. We can also evaluate on the production steps by analyzing multiple lots of biopharmaceutical product. This is especially useful for you if you have an interest in comparing your biosimilar product to competitors with similar products or to the original product manufacturer.

You receive a report with lists of HCPs and their physiochemical properties (MW, pI, AA sequence, database accession number) for both the biosimilar and the originator analysis.

Your guarantee for world-class results

All analyses are conducted according to the ICH Q6B guidelines – Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. Furthermore, we always guarantee you that PhD-level scientists are involved in your project to apply their extensive knowledge, and ensure both fast turnaround-time and in-depth Host Cell Protein characterization.

Note, this mass spectrometry-based (LC-MS) analysis does not require access to any HCP ELISA reagents. We simply need to know the host organism and any other proteins that you add during the biologic’s process development.

You can choose and combine your preferred biosimilar analysis package from the services below:

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More info

When producing a biosimilar – a generic version of an original biotherapeutic reference product (innovator) – both biological potency, safety, and efficacy must be assessed during the characterization process. This is especially important for quality assurance purposes and to obtain approval from regulatory agencies like FDA and EMA.

The above services can be utilized for e.g. non-GLP exploratory studies, pre-clinical, and clinical development processes. They also serve as tools for various purification steps, including to remove process-related impurities. With top-of-the-line instruments, PhD-level scientists and the latest industry knowledge of protein analysis, biosimilar analytical comparability is in place for all analyses.

Chromatography and mass spectrometry are combined as the center of our analytics, which ensures high reproducibility and high throughput. The analyses can be applied to all types of biosimilar products, where the active pharmaceutical ingredient (API) is protein. Examples include monoclonal antibodies, Fc-fusion proteins, interleukins and other cytokines, and recombinant proteins like insulin and erythropoietin.

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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