Biosimilar analysis

Detailed analysis of biosimilars and comparison to originator

Alphalyse may analyze any biosimilar and compare it to its originator product for direct comparison. We can also evaluate on the production steps by analyzing multiple lots of biopharmaceutical product. This is especially useful for manufacturers with interest in comparing their own product / biosimilar to competitors with similar products.

All analyses...

Alphalyse may analyze any biosimilar and compare it to its originator product for direct comparison. We can also evaluate on the production steps by analyzing multiple lots of biopharmaceutical product. This is especially useful for manufacturers with interest in comparing their own product / biosimilar to competitors with similar products.

All analyses are conducted according to the ICH Q6B guidelinesTest Procedures and Acceptance Criteria for Biotechnological/Biological Products.

You can choose and combine your preferred 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.

Experts

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

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