Peptide analysis

Analytic services for peptide identity

Alphalyse offers full characterization of your unique peptide-based product. We utilize nanoLC-MS/MS for the analysis if the purified peptide is of low abundance. Consequently, we can analyze your sample even if the sample amount is limited. With the results, you can optimize the development and production of your peptide.

All tests are performed accord...

Alphalyse offers full characterization of your unique peptide-based product. We utilize nanoLC-MS/MS for the analysis if the purified peptide is of low abundance. Consequently, we can analyze your sample even if the sample amount is limited. With the results, you can optimize the development and production of your peptide.

All tests are performed 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:

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Peptides are increasingly used as the active pharmaceutical ingredient (API) in biologics, and we conduct more and more characterization projects of biological peptides. Typical analyses of peptide therapeutics investigate the peptide identity, sequence, heterogeneity, intact mass, stability, degradation products, quantity of individual amino acids, etc.

Comprehensive analytical characterization of a peptide drug product is needed to achieve regulatory approval, as well as define and monitor critical quality attributes (CQA).

Our experience with peptides is closely connected and updated by a strong collaboration with the Protein Research Group at the University of Southern Denmark (SDU), world famous for its proteomics and protein research.

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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