Biofidus
Contract research organization offering laboratory-based analytical characterization and fit-for-purpose method development for biologics, biosimilars, cell and gene therapies, and related small-molecule analyses. Services include orthogonal structural and functional analytics, stability and forced-degradation studies, developability assessments, viral vector and CGT analytics, and ICH-aligned method qualification to support CMC and regulatory decision-making.
Industries
Nr. of Employees
small (1-50)
Biofidus
Services
Orthogonal workflows for primary structure, PTMs, glycosylation, charge and size variants, binding and potency to support CMC and comparability questions.
Integrated AAV and cell-and-gene-therapy analytics including long-read sequencing for genome integrity, qPCR titering, capsid PTM analysis, empty/full assessment and impurity profiling.
Design and execution of ICH-aligned forced-degradation and stability programs with stability-indicating analytical readouts to support shelf-life and comparability.
Early-stage panels combining aggregation, charge, glycosylation, higher-order structure and functional assays to inform lead selection and manufacturability.
Chromatographic and mass-spectrometric assays for metabolites, vitamins, neurotransmitters and spent media to support bioprocess development and CMC.
State-of-the-art analytical workflows for nanobodies and single-domain antibodies covering primary structure, PTMs, charge and size heterogeneity, aggregation, higher-order structure and tailored functional assays.
Orthogonal workflows for primary structure, PTMs, glycosylation, charge and size variants, binding and potency to support CMC and comparability questions.
Integrated AAV and cell-and-gene-therapy analytics including long-read sequencing for genome integrity, qPCR titering, capsid PTM analysis, empty/full assessment and impurity profiling.
Design and execution of ICH-aligned forced-degradation and stability programs with stability-indicating analytical readouts to support shelf-life and comparability.
Early-stage panels combining aggregation, charge, glycosylation, higher-order structure and functional assays to inform lead selection and manufacturability.
Chromatographic and mass-spectrometric assays for metabolites, vitamins, neurotransmitters and spent media to support bioprocess development and CMC.
State-of-the-art analytical workflows for nanobodies and single-domain antibodies covering primary structure, PTMs, charge and size heterogeneity, aggregation, higher-order structure and tailored functional assays.
Expertise Areas
- Analytical characterization of biologics and biosimilars
- Biophysical and higher-order structure analysis
- Method development, qualification and transfer (ICH-aligned)
- Stability and forced-degradation studies
Key Technologies
- Peptide mapping by LC-MS/MS
- Intact mass analysis by LC-MS
- Reversed-phase chromatography (RP)
- Size-exclusion chromatography (SEC)
News & Updates
Poster describing a workflow linking high-throughput expression/selection with mechanistic ADCC-relevant characterization; reports changes in FcγRIIIa affinity with afucosylation and variant combinations.
Article discussing updated FDA draft Q&As emphasizing analytical comparability in biosimilar programs.
Announcement of acquisition/membership in the Midas group to expand structural and functional characterization service offerings.
Website reports >1,000 projects completed, >300 clients served, 1,300 m² lab space, and presence in 30+ countries via affiliates.
Poster describing a workflow linking high-throughput expression/selection with mechanistic ADCC-relevant characterization; reports changes in FcγRIIIa affinity with afucosylation and variant combinations.
Article discussing updated FDA draft Q&As emphasizing analytical comparability in biosimilar programs.
Announcement of acquisition/membership in the Midas group to expand structural and functional characterization service offerings.
Website reports >1,000 projects completed, >300 clients served, 1,300 m² lab space, and presence in 30+ countries via affiliates.