Protein analysis

Comprehensive analysis of your protein-based product

Alphalyse services are optimized for a wide range of protein sample types. They can be customized to fit your specific protein product, with the aim to strengthen your process development and production throughout the project.

We conduct all analyses according to the ICH Q6B guidelines – Test Procedures and Acceptance Criteria for Biotechnological/Biolo...

Alphalyse services are optimized for a wide range of protein sample types. They can be customized to fit your specific protein product, with the aim to strengthen your process development and production throughout the project.

We conduct all analyses according to the ICH Q6B guidelines – Test Procedures and Acceptance Criteria for Biotechnological/Biological Products.

You can choose and combine your preferred analysis package from the services below or end us your project description so we can design a service package that meets your needs.

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Protein characterization is crucial in both research and process development of biologics, before research can be validated and pharmaceutical products can reach clinical administration. Therefore, experience and knowledge of analytical approaches must be of the highest quality to ensure thorough protein characterization. After offering protein analysis for more than 15 years, we have investigated and detected millions of proteins.

Both the Alphalyse founders and several employees share a close relation to the Protein Research Group at the University of Southern Denmark (SDU), known all over the world for its advances within protein science. Together with the newest instruments on the market, this ensures that we are a world leading CRO within protein analysis.

We are heavily experienced working with recombinant proteins, such as enzymes, hormones and growth factors, as well as their derivatives and relatives, e.g. host cell proteins (HCPs), peptide fragments and proteases.

Typically, several analyses are combined to completely characterize proteins by their size, structure and physiochemical properties. For batch release testing, it could include intact mass and peptide fragmentation analysis, characterization of post translational modifications, sequence verification and analysis of impurities, both process- and product-related.

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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