FyoniBio SA provides services for biologics development, bioanalytical characterization and clinical trial laboratory support. Its service portfolio includes cell-line development, process development, mass spectrometry analytics, clinical bioanalysis and functional/potency bioassays, and its laboratories follow GCLP standards with ISO 9001:2015 certification.
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Full suite of biologics development services, integrated workflows or standalone solutions from concept to scalable manufacturing, including cell line development, process optimization and bioanalytics.
Cell Line Development
Mammalian cell line development for biotherapeutics, including CHO and human expression systems, host cell line feasibility studies, and platform-based development with CHOnamite®, CHOFlow® and GlycoExpress®.
Process Development
Integrated upstream and downstream process development, including batch, fed-batch, intensified fed-batch and perfusion modes, purification, formulation development, stability studies and tech transfer support.
Bioanalytical Characterization
Bioanalytical characterization of biologics across development stages, including biochemical analytics, mass spectrometry, functional and potency assessments, comparability studies and regulatory-ready documentation.
Mass Spectrometry Analytics
Mass spectrometry-based characterization of biotherapeutics, including intact mass, glycan profiling, glycopeptides, peptide mapping, PTM analysis and antibody-drug conjugate DAR assessment.
Functional and Potency Bioassays
Custom functional and potency assays for target binding, signaling, cell viability, cytotoxicity, immuno-oncology and other cell-based readouts, including assay development and validation.
Clinical Bioanalysis
GCLP-compliant clinical bioanalysis for PK, PD and immunogenicity, including assay development, validation and clinical sample analysis for serum, plasma and other matrices.
Bioanalytical Support for Clinical Trials
End-to-end bioanalytical support for clinical trials from Phase I to IV, including assay selection, validation, sample analysis, regulatory documentation and patient-stratification support.
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