About

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. About FyoniBio FyoniBio is a CDO and clinical laboratory offering custom-tailored services at different drug development stages to pharmaceutical and biotechnology companies. At FyoniBio, we leverage 15 years of specialized expertise in biopharmaceutical CMC development to deliver cutting-edge scientific solutions as a Contract Development Organization (CDO). Our integrated ISO-9001:2015 services encompass the entire spectrum of biopharmaceutical development, from crafting stable high-titre cell lines in mammalian expression systems to meticulous process development and rigorous quality control. With comprehensive bioanalytical capabilities tailored for preclinical and clinical studies, we empower biopharmaceutical companies to accelerate their CMC projects with confidence, precision, and reliability. At FyoniBio, our commitment to excellence extends beyond our expertise in biopharmaceutical CMC. A special focus lies on our versatile and robust cell line portfolio, which includes our highly productive CHO platform technology CHOnamite® (for high-yield production of up to 10 g/L), our proprietary CHOFlow® cell line (a FUT-8 KO cell for ADCC enhanced afucosylated mAbs), as well as the human GlycoExpress® platform (for complex glycoproteins). Coupled with upstream and downstream process optimization, state-of-the-art equipment, and in-house developed software for glycan analytics, our comprehensive services ensure unparalleled efficiency and quality throughout the development process. Moreover, our service portfolio is complemented by GCLP-compliant bioanalysis of clinical samples, including pharmacokinetics, genotyping, biomarker, and immunogenicity assessment, providing a seamless integration of scientific capabilities from development to clinical trials. Our powerful cell line portfolio is strengthened with: • Customized feasibility studies to select the best suitable host cell line meeting the requirements for each individual complex recombinant protein. • State-of-the-art cell line development using the CellCelector technology to select highest expressing clones meeting the monoclonality requirements • Integrated robust upstream (USP) and downstream (DSP) development, as well as analytical development, to competitive accelerate timelines. • Extensive protein characterization (e.g., PTMs; N-glycans; O-glycans) ensured by our in-depth expertise in mass spectrometry. • Bioassay development (e.g., ADCC, CDC; ELISA, FACS). • Clinical bioanalysis (PK, ADA) for proteins and oligonucleotides under GCLP regulations. About FyoniBio GmbH FyoniBio is a CDO and clinical laboratory offering custom-tailored services at different drug development stages to pharmaceutical and biotechnology companies. At FyoniBio, we leverage 15 years of specialized expertise in biopharmaceutical CMC development to deliver cutting-edge scientific solutions as a Contract Development Organization (CDO). Our integrated ISO-9001:2015 services encompass the entire spectrum of biopharmaceutical development, from crafting stable high-titre cell lines in mammalian expression systems to meticulous process development and rigorous quality control. With comprehensive bioanalytical capabilities tailored for preclinical and clinical studies, we empower biopharmaceutical companies to accelerate their CMC projects with confidence, precision, and reliability. At FyoniBio, our commitment to excellence extends beyond our expertise in biopharmaceutical CMC. A special focus lies on our versatile and robust cell line portfolio, which includes our highly productive CHO platform technology CHOnamite® (for high-yield production of up to 10 g/L), our proprietary CHOFlow® cell line (a FUT-8 KO cell for ADCC enhanced afucosylated mAbs), as well as the human GlycoExpress® platform (for complex glycoproteins). Coupled with upstream and downstream process optimization, state-of-the-art equipment, and in-house developed software for glycan analytics, our comprehensive services ensure unparalleled efficiency and quality throughout the development process. Moreover, our service portfolio is complemented by GCLP-compliant bioanalysis of clinical samples, including pharmacokinetics, genotyping, biomarker, and immunogenicity assessment, providing a seamless integration of scientific capabilities from development to clinical trials. Our powerful cell line portfolio is strengthened with: • Customized feasibility studies to select the best suitable host cell line meeting the requirements for each individual complex recombinant protein. • State-of-the-art cell line development using the CellCelector technology to select highest expressing clones meeting the monoclonality requirements • Integrated robust upstream (USP) and downstream (DSP) development, as well as analytical development, to competitive accelerate timelines. • Extensive protein characterization (e.g., PTMs; N-glycans; O-glycans) ensured by our in-depth expertise in mass spectrometry. • Bioassay development (e.g., ADCC, CDC; ELISA, FACS). • Clinical bioanalysis (PK, ADA) for proteins and oligonucleotides under GCLP regulations. At FyoniBio, we leverage 15 years of specialized expertise in biopharmaceutical CMC development to deliver cutting-edge scientific solutions as a Contract Development Organization (CDO). Our integrated ISO-9001:2015 compliant services encompass the entire spectrum of biopharmaceutical development, from crafting stable high-titre cell lines in mammalian expression systems to meticulous process development and rigorous quality control. With comprehensive bioanalytical capabilities tailored for preclinical and clinical studies, we empower biopharmaceutical companies to accelerate their CMC projects with confidence, precision, and reliability. At FyoniBio, our commitment to excellence extends beyond our expertise in biopharmaceutical CMC. A special focus lies on our versatile and robust cell line portfolio, which includes our highly productive CHO platform technology CHOnamite® (for high-yield production of up to 12 g/L), our proprietary CHOFlow® cell line (a FUT-8 KO cell for ADCC enhanced afucosylated mAbs), as well as the human GlycoExpress® platform (for complex glycoproteins). Coupled with upstream and downstream process optimization, state-of-the-art equipment, and in-house developed software for glycan analytics, our comprehensive services ensure unparalleled efficiency and quality throughout the development process. Moreover, our service portfolio is complemented by GCLP-compliant bioanalysis of clinical samples, including pharmacokinetics, genotyping, biomarker, and immunogenicity assessment, providing a seamless integration of scientific capabilities from development to clinical trials. Our powerful cell line portfolio is strengthened with: • Customized feasibility studies to select the best suitable host cell line meeting the requirements for each individual complex recombinant protein. • State-of-the-art cell line development using the CellCelector technology to select highest expressing clones meeting the monoclonality requirements • Integrated robust upstream (USP) and downstream (DSP) development, as well as analytical development, to competitive accelerate timelines. • Extensive protein characterization (e.g., PTMs; N-glycans; O-glycans) ensured by our in-depth expertise in mass spectrometry. • Bioassay development (e.g., ADCC, CDC; ELISA, FACS). • Clinical bioanalysis (PK, ADA) for proteins and oligonucleotides under GCLP regulations.