Antibody characterization
Antibody Characterization
As major components of the humoral immunity and thanks to their very high specificity, IgGs have been the major focus for the development of biologics for decades. Even being the most commonly used biologics for cutting edge therapies, their structural and physicochemical characterization always require a sequence of complex analytical assays.
Nevertheless, the analysis and detailed characterization of these highly complex biomolecules is a daily routine for us at Biofidus. Our portfolio includes in-depth analysis of the protein primary structure, amino acid modifications, as well as binding or functionality in cell-based assays. 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 (DS), 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
- Initial protein characterization
- Developability assessment
- Clone selection / lead selection
- Impurity characterization
- Forced degradation studies
- Stability testing
- Comparability/biosimilarity studies
- Formulation development
- Process characterization
- Setup, transfer and qualification of analytical methods
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 isoelectric focusing (cIEF)
- Capillary zone electrophoresis (CZE)-UV
- (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
- qPCR
- Analytical ultracentrifugation (AUC)
- Circular dichroism (CD)
- Differential scanning calorimetry (DSC)
- Dynamic light scattering (DLS)
- Fourier transform infrared (FTIR) spectroscopy
Our CEO Dr. Benjamin Müller advices you on all your requests concerning the general topic of protein characterization.
Phone: +49 (0)521 329 363 41
Mail: Benjamin.Mueller@Biofidus.com