With a history in ISO-9001 compliant contract development services in the last 15 years FyoniBio provides solutions for supporting the customers in their biopharma development program.
Our offerings include:
• Cell line Development using human GlycoExpress® and rodent CHOnamite®: Start with fast and cost-efficient feasibility studies to identify the best cell host for your biopharma project.
• USP, DSP , Formulation and analytical development: We establish and deliver the full package to hand over for GMP manufacturing.
• Mass Spectrometry based PTM and protein analytics: For in depth protein characterization, we provide MS based protein and PTM analytics to include into clone development to identify the clone providing the best quality, stability studies or full final protein characterization for IND submission.
• Bioassay development: Cell based assays like ADCC, CDC, ADCP, cell activation assays, killing assays, cell binding assays as well as biochemical assays like antigen binding (e.g. affinity determination, FcgR binding, in-vitro activity assays)
• Clinical bioanalysis/immunomonitoring: Evaluation of pharmacokinetic and pharmacodynamic characteristics of biotherapeutics as well as their immunogenic and neutralizing potential in patients like analysis for anti-drug-antibodies (ADAs) using screening/confirmatory/titration assays, Analysis of ADA for neutralizing activity, PK analysis, biomarker serum levels.
Our offerings include:
• Cell line Development using human GlycoExpress® and rodent CHOnamite®: Start with fast and cost-efficient feasibility studies to identify the best cell host for your biopharma project.
• USP, DSP , Formulation and analytical development: We establish and deliver the full package to hand over for GMP manufacturing.
• Mass Spectrometry based PTM and protein analytics: For in depth protein characterization, we provide MS based protein and PTM analytics to include into clone development to identify the clone providing the best quality, stability studies or full final protein characterization for IND submission.
• Bioassay development: Cell based assays like ADCC, CDC, ADCP, cell activation assays, killing assays, cell binding assays as well as biochemical assays like antigen binding (e.g. affinity determination, FcgR binding, in-vitro activity assays)
• Clinical bioanalysis/immunomonitoring: Evaluation of pharmacokinetic and pharmacodynamic characteristics of biotherapeutics as well as their immunogenic and neutralizing potential in patients like analysis for anti-drug-antibodies (ADAs) using screening/confirmatory/titration assays, Analysis of ADA for neutralizing activity, PK analysis, biomarker serum levels.
BIO DOUBLE HELIX SPONSORS
BIO HELIX SPONSORS
