Biofidus
Biofidus AG is a bioanalytical contract research organization (CRO) based in Bielefeld, Germany. The company provides structural and functional characterization services for protein therapeutics (including antibodies and nanobodies), gene- and cell-therapy vectors, and related small-molecule analyses. Core activities include mass-spectrometry and chromatography-based analytics, electrophoretic and biophysical assays, sequencing and qPCR workflows, stability and forced-degradation testing, biosimilar/comparability packages and ICH-guided method qualification. Biofidus was founded in 2015 and is part of the Midas group.
Industries
Nr. of Employees
small (1-50)
Biofidus
Bielefeld, Nordrhein-Westfalen, Germany, Europe
Services
Analytical comparability packages for biosimilars and process changes including glycan profiling, charge-variant analysis, potency assays and PK-focused support aligned to ICH Q5E guidance.
Sequence verification and targeted PTM identification/quantification using peptide mapping and LC-MS workflows.
Aggregate and subvisible particle quantification and characterization using SEC-UV, AF4, AUC, MFI and orthogonal techniques.
Functional testing using SPR, ELISA and tailored cell-based assays for potency, neutralization and activity linkage to structural changes.
Structural and quantitative glycan analysis to assess glycosylation patterns relevant for function and stability.
Sequence verification and intact mass determination to confirm identity and detect truncations or chemical modifications.
Analytical comparability packages for biosimilars and process changes including glycan profiling, charge-variant analysis, potency assays and PK-focused support aligned to ICH Q5E guidance.
Sequence verification and targeted PTM identification/quantification using peptide mapping and LC-MS workflows.
Aggregate and subvisible particle quantification and characterization using SEC-UV, AF4, AUC, MFI and orthogonal techniques.
Functional testing using SPR, ELISA and tailored cell-based assays for potency, neutralization and activity linkage to structural changes.
Structural and quantitative glycan analysis to assess glycosylation patterns relevant for function and stability.
Sequence verification and intact mass determination to confirm identity and detect truncations or chemical modifications.
Expertise Areas
- Bioanalytical characterization of protein therapeutics (antibodies, nanobodies and fusion proteins)
- Biosimilar comparability and regulatory-aligned analytical strategies
- Mass-spectrometry-based peptide mapping and multi-attribute monitoring
- Chromatography and electrophoretic methods for purity and charge analysis
Key Technologies
- LC-ESI-MS/MS peptide mapping
- Intact mass LC-MS
- MALDI-TOF mass spectrometry
- Multi-attribute monitoring (MAM)
News & Updates
Service page describing analytical workflows and comparability assessments aligned to ICH guidelines for biosimilar development and process changes.
Blog article discussing regulatory developments enabling biosimilar approvals with reduced reliance on comparative clinical efficacy studies and the increased role of analytical comparability.
Announcement of Biofidus joining the Midas group and expansion of services, including implementation of a GMP environment at Biofidus.
Case study describing peptide mapping with LC-ESI-MS and a cell-based TNF-α neutralization assay to link PTMs to functional loss in a therapeutic fusion protein example.
Biofidus became a member of the Midas group, expanding service capabilities and planning implementation of a GMP environment.
Service page describing analytical workflows and comparability assessments aligned to ICH guidelines for biosimilar development and process changes.
Blog article discussing regulatory developments enabling biosimilar approvals with reduced reliance on comparative clinical efficacy studies and the increased role of analytical comparability.
Announcement of Biofidus joining the Midas group and expansion of services, including implementation of a GMP environment at Biofidus.
Case study describing peptide mapping with LC-ESI-MS and a cell-based TNF-α neutralization assay to link PTMs to functional loss in a therapeutic fusion protein example.
Biofidus became a member of the Midas group, expanding service capabilities and planning implementation of a GMP environment.