Comparability studies
Comparability studies play a crucial role in the evaluation of process changes during the manufacturing of biopharmaceutical products. The purpose of comparability studies is to show that the pre- and post-change compounds are comparable in terms of quality, efficacy and safety. Furthermore, comparability studies are required to generate evidence that demonstrates sufficient similarity (not identity) of biosimilars and the originator products with respect to their critical quality attributes (CQAs).
Comparability studies embrace complex and comprehensive analytical pipelines to determine the physicochemical properties, biological activity, product- and process related impurities as well as the stability of pharmaceutical drugs to ensure no adverse impact on their quality, safety and efficacy. Our vast experience and deep knowledge in assessing the impact of heterogeneities allows us to predict if a product will meet consistently approved specifications.
Biofidus offers a holistic and state-of-the-art comparability assessment service according to the ICH Q5 E guideline, to accelerate the approval of your biosimilars or process changes and to minimize the risk of later stage setbacks.
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
- Sourcing of reference products (Originators)
- Readily available analytical data of historical originator batches
- Method qualification according to ICH guidelines
- Tailored analytical service in accordance with ICH Q5 E guideline
- Reduction of cost and time to market
Standalone and integral bioanalytical services
PROTEIN SEQUENCE ANALYSIS
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 comparability assessments.
Phone: +49(0)521 89 739 060
Mail: Benjamin.Mueller@Biofidus.com
