Hormones
Hormone analysis
Hormones act as are regulatory chemical messengers to maintain homeostasis and play a fundamental role in the functionality of various organs and tissues. As hormones are heavily involved in a wide range of physiological processes like, growth, reproduction, metabolism, stress response or immune function, synthetic copies of natural occurring hormones are heavy weights of medical treatments since several decades. Unlike rather simple hormone subclasses like steroids, the analysis of highly glycosylated protein-based hormones like Erythropoietin (EPO) requires a sequence of complex analytical assays in order to ensure the structural and functional integrity of the biomolecule.
Biofidus offers standardized high-throughput analytical pipelines for small sized hormones as well as a holistic and state-of-the-art analytical service platform for an in-depth analysis of the protein primary structure, amino acid modifications, purity, concentration, as well as functionality in cell-based assays of protein-based hormones. We are specialists in determining protein glycosylation structures, which are among the most important protein modifications having significant influence on function and stability of biopharmaceutical molecules.
Our vast experience and deep knowledge in this field allows us to guide you through the variety of available methods and help you find the optimal analytical solution for your project. In accordance with your needs, we adapt and, if required, qualify (according to ICH guidelines) our platform methods tailored to your drug substance, its individual formulation matrix and your distinct analytical question.
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
- Assessment of structural and functional integrity
- In-depth analysis of PTMs
- Bioactivity assessment
- Purity characterization
- Compound quantification
- Sourcing of reference products (Originators)
- Real-time and accelerated stability studies
- Forced degradation studies
- Method qualification according to ICH guidelines
- Minimal lead time and fast project timelines
Tell us about your project
We‘ll advice you to define your assay needs
Technologies used
- LC-ESI-MS/MS peptide mapping
- LC-ESI-MS intact mass analysis
- Reversed phase (RP) chromatography
- Size exclusion chromatography (SEC)
- Hydrophilic interaction chromatography (HILIC)
- Hydrophobic interaction chromatography (HIC)
- Ion exchange chromatography (IEX)
- High performance anion exchange chromatography with pulsed amperometric detection (HPAEC-PAD)
- Absolute protein quantification (AQUA)
- Capillary gel electrophoresis (CGE)
- Capillary zone electrophoresis (CZE)-UV
- Capillary isoelectric focusing (cIEF)
- (2D-)SDS-PAGE
- Gel based isoelectric focusing (IEF)
- Western blot
- ELISA
- Surface plasmon resonance (SPR)
- Cell-based assays
- Plasma/serum stability assays
- Nanopore DNA/RNA sequencing (ONT)
- qPCR
- Circular dichroism (CD)
- Differential scanning calorimetry (DSC)
- Dynamic light scattering (DLS)
- (2D-)SDS-PAGE
- Fourier transform infrared (FTIR) spectroscopy
Our Expert Tobias Luttermann advices you on for all analytical requests related to hormones.
Phone: +49 (0)521 329 363 41
Mail: Tobias.Luttermann@Biofidus.com