Peptides & Hormones

Peptide and Hormone Characterization 

Hormones and peptide drugs act as regulatory chemical messengers that maintain homeostasis and control key physiological processes such as growth, reproduction, metabolism, stress response and immune function. In recent years, there has been a major industry shift towards peptide-based therapeutics, including GLP-1 receptor agonists like semaglutide and related incretin mimetics, which are transforming treatment paradigms in metabolic disease, obesity and diabetes and driving a strong global focus on peptide drug development and lifecycle management.

While small peptide hormones and synthetic peptide drugs can often be analyzed using standardized, high-throughput workflows, highly glycosylated protein-based hormones such as erythropoietin (EPO) and other glycoprotein hormones require a coordinated sequence of complex analytical assays to ensure their structural and functional integrity.

For both modern peptide drugs (e.g. GLP-1 analogues, incretin mimetics) and classical protein hormones, subtle changes in primary structure, post-translational modifications, glycosylation or higher-order structure can significantly impact potency, half-life, stability and immunogenicity, making dedicated peptide and hormone characterization a critical success factor in today’s pharma pipelines.

At Biofidus, we offer standardized high-throughput analytical pipelines for small peptide hormones and peptide drugs, as well as a holistic, state-of-the-art analytical platform for protein-based hormones. Our services cover in-depth primary structure and sequence confirmation, amino acid and post-translational modifications (PTMs), purity and concentration determination, and mechanism-of-action–relevant cell-based assays to evaluate biological functionality.

We are specialists in protein glycosylation analysis, one of the most important modifications influencing function, stability and safety of therapeutic hormones. Our extensive experience allows us to guide you through the available methods and define the optimal, ICH-aligned analytical strategy for your peptide or hormone project.

In accordance with your needs, we adapt and, where required, qualify our platform methods according to ICH guidelines, tailored to your drug substance, its individual formulation matrix and your specific analytical questions.

Get in contact with us to quickly find the optimal setup for your analytical challenge and to speak directly from expert to expert

Our Capabilities

  • Identity, primary structure and sequence integrity
  • Specific activity and biological potency
  • Post-translational modifications
  • Glycosylation profile
  • Purity
  • Aggregation, size variants and particles
  • Charge variants and isoforms
  • Higher-order structure
  • Stability studies

Just what you need? Contact us!

Standalone and integral bioanalytical services

TECHNOLOGIES USED

  1. LC-ESI-MS/MS peptide mapping
  2. LC-ESI-MS intact mass analysis
  3. Reversed phase (RP) chromatography
  4. Size exclusion chromatography (SEC)
  5. Hydrophilic interaction chromatography (HILIC)
  6. Hydrophobic interaction chromatography (HIC)
  7. Ion exchange chromatography (IEX)
  8. High performance anion exchange chromatography with pulsed amperometric detection (HPAEC-PAD)
  9. Absolute protein quantification (AQUA)
  10. Capillary gel electrophoresis (CGE)
  11. Capillary zone electrophoresis (CZE)-UV
  12. Capillary isoelectric focusing (cIEF)
  13. (2D-)SDS-PAGE
  14. Gel based isoelectric focusing (IEF)
  15. Western blot
  16. ELISA
  17. Surface plasmon resonance (SPR)
  18. Cell-based assays
  19. Plasma/serum stability assays
  20. Nanopore DNA/RNA sequencing (ONT)
  21. qPCR
  22. Circular dichroism (CD)
  23. Differential scanning calorimetry (DSC)
  24. Dynamic light scattering (DLS)
  25. (2D-)SDS-PAGE
  26. Fourier transform infrared (FTIR) spectroscopy

Tell us about Your Project

We‘ll advise you to define your assay needs.

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Our Expert

Dr. Thomas Schachtsiek advises you on for all analytical requests related to hormones.
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