Protein characterization

Comprehensive analysis of your protein-based product

Do you need customized protein characterization services? For instance for identification, quantification and sequencing of your biopharmaceutical protein and its product-related impurities?

Or are you are looking to analyze process-related impurities, e.g. Host Cell Proteins (HCPs) throughout your purification steps and in clinical GMP-batches?

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Do you need customized protein characterization services? For instance for identification, quantification and sequencing of your biopharmaceutical protein and its product-related impurities?

Or are you are looking to analyze process-related impurities, e.g. Host Cell Proteins (HCPs) throughout your purification steps and in clinical GMP-batches?

What can you achieve with mass spectrometry-based characterization?

  • Confirm your protein sequence and find sequence variants and degradation products. Analyze protein stability and quantify modifications.
  • Or find the HCP ELISA with highest coverage for your drug and process HCPs.
  • Also, you can get the identity and quantity of all individual proteins in your samples, including residual HCPs.

Alphalyse protein services are optimized for a wide range of protein-based biologics. With experience from thousands of analytical runs, and more than 100 HCP analysis projects, we are a an experienced protein characterization CRO. And we offer established and validated workflow for most expression systems and sample types.

Standard or customized protein characterization

The analyses can be customized to fit your specific protein product, with the aim to strengthen your process development and production throughout the project. You can choose and combine your preferred analysis package from the services below. Or, you can send us your project description so we can design an analysis package that meets your needs.

We conduct all protein analyses according to the ICH Q6B guidelines – Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. All repetitive tasks are automated. This way, you are ensured a high reproducibility and fast reporting time.

You can select one or combine several protein characterization analyses from the list below, depending on your project needs.

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We offer customized solutions, contact us to discuss your project.

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Typical questions

Why should you characterize protein?

Protein characterization is crucial for validation of research and to reach clinical administration of biologics. Therefore, experience and knowledge of analytical approaches must be of highest quality to ensure thorough protein characterization.

Which analysis does characterization of protein consist of?

Typically, several analyses are combined for complete characterization of protein size, structure, and physiochemical properties. It could include intact mass and peptide fragmentation analysis, characterization of post translational modifications, sequence verification, and also analysis of impurities.

Why choose Alphalyse for protein characterization?

Alphalyse has close relations to the Protein Research Group at the University of Southern Denmark (SDU), known worldwide for its advances within protein science. We are heavily experienced with characterization of recombinant proteins, such as enzymes, hormones, growth factors, and their derivatives and relatives like host cell proteins (HCPs), peptide fragments, and proteases.

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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