Biosimilar analysis

Detailed analysis of biosimilars and comparison to originator

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

For the approval of originator products, comprehensive documentation of Host Cell Proteins (HCPs) must be available. Even though biosimilars contain the same active product ingredient (API), analysis shows that the HCP content might not be t...

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

For the approval of originator products, comprehensive documentation of Host Cell Proteins (HCPs) must be available. Even though biosimilars contain the same active product ingredient (API), analysis shows that the HCP content might not be the same. Thus, the API might have a 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.

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

What you gain from a collaboration with us

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

With the Alphalyse HCP biosimilar 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 the production steps by analyzing multiple lots of biopharmaceutical products. It is beneficial if you are interested in comparing your biosimilar product to competitors with similar products or the original product manufacturer.

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

Your guarantee of world-class results

All analyses are conducted according to the ICH Q6B guidelines – Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. Furthermore, we guarantee 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 analysis.

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

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

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Why is biosimilar analysis important?

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 analysis process. This is especially important for quality assurance purposes and to obtain approval from regulatory agencies, e.g. FDA/EMA.

How can you use biosimilar vs originator analysis results?

The results can be utilized for non-GLP exploratory studies, pre-clinical, clinical development processes, etc. They also serve as tools in various purification steps, e.g. to remove process-related impurities, as well as make a direct comparison to the originator product.

Which biosimilar products can be analyzed with mass spec?

When combined, chromatography and mass spectrometry ensure high data 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 projects.

Analytical experts

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

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