Biosimilar studies
Biosimilar studies. We know what to do.
Experience top-tier biosimilar assessment services with Biofidus. Our biosimilar assessments focus on generating evidence that showcases the significant similarity (not identity) between biosimilars and originator products, specifically concerning critical quality attributes (CQAs).
Our biosimilar studies feature intricate and comprehensive analytical pipelines. We delve into physicochemical properties, biological activity, product- and process-related impurities, and pharmaceutical drug stability to ensure no adverse impacts on quality, safety, and efficacy. Drawing on our extensive experience and profound knowledge of assessing heterogeneities, we can predict a product’s consistency in meeting approved specifications.
Biofidus offers a holistic and state-of-the-art biosimilar and comparability assessment service according to the ICH Q5E 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)
- Establishment of originator quality target product profile (QTPP)
- 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
Extensive experience with :
Standalone and integral bioanalytical services
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)521 329 363 41
Mail: Benjamin.Mueller@Biofidus.com