Developability studies
Developability studies. Bet on the right horse.
The journey from discovery to commercialization of new biopharmaceutical drugs is always time-consuming and costly. In this respect, it is of utmost importance to determine decisive factors for a successful lead selection such as manufacturability, biophysical properties and pharmacokinetics as quickly as possible in order to ensure a targeted development.
Biofidus provides a holistic and state-of-the-art developability assessment service for your lead candidates, to accelerate your pipeline and to minimize the risk of later stage setbacks. Our assessment provides a bridge between product knowledge and process understanding. Our developability assessment helps you to optimize the efficacy, safety and overall quality of your biologics at an early stage of development.
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 success factors (biophysics, manufacturing, pharmacokinetics)
- Identification of potential risks of manufacturing and clinical trials
- Advice on lead selection
- Reduction of cost and time to market
- Stability studies
- Accelerated stability studies
- Forced degradation studies
- Method qualification according to ICH guidelines
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 inquiries concerning our developability assessments.
Phone: +49 (0)521 329 363 41
Mail: Benjamin.Mueller@Biofidus.com