Website: https://www.fyonibio.com/
Company headquarters: Berlin
Year founded: 1 February 2022 — spin-out from Glycotope GmbH
Number of employees: 35+
Main contact person in the Bio-PAT network: Dr. Lena Tholen
Position in the company: Head of Cell Line and Bioprocess Development
Products / product groups / services / competencies:
FyoniBio is a biologics service provider with over 15 years of scientific expertise and a proven track record of supporting more than 100 biologics projects for biotech and pharma companies worldwide. Trusted by partners whose products have reached clinical development in both FDA and EMA regions, FyoniBio offers a broad service portfolio covering the entire development chain — from cell line and process development to analytical characterization and clinical bioanalysis under GCLP.
Our team combines deep scientific understanding with flexibility and transparent communication to deliver tailored solutions that meet each project’s specific needs. All services are performed under our ISO 9001–certified quality management system, ensuring full compliance with international ISO and ICH standards.
FyoniBio supports cell line development from the first evaluation of the DNA vector construct to the selection of stable, high-producing clones. Our approach combines scientific experience, traceable documentation, and flexible expression platforms to generate production cell lines tailored to the needs of each molecule.
We provide complete cell line development support, including evaluation of suitable expression systems, clone selection, full cell history documentation in line with EMA and FDA expectations, and technology transfer to GMP manufacturers. Depending on the project, production cell lines can reach titers of up to 12 g/L and may be glyco-optimized where needed.
Our expression platforms include:
CHOnamite® — FyoniBio’s versatile CHO expression platform, built on CHO-K1, CHO-GS-KO, and CHO-DG44 cell lines. It supports the development of high-performing production cell lines for antibodies, bispecifics, biosimilars, and other complex recombinant proteins.
GlycoExpress® — a human screening and expression platform for complex or difficult-to-express proteins. Its proprietary glyco-optimized human cell lines generate biotherapeutics with authentic human glycosylation patterns, free from non-human carbohydrate residues.
CHOFlow® — a glyco-engineered CHO-K1 FUT8 knockout cell line developed for the production of afucosylated monoclonal antibodies with enhanced antibody-dependent cellular cytotoxicity (ADCC).
FyoniBio develops upstream and downstream processes that support biologics on their way from early development to GMP production. Our focus is on building efficient, scalable, and reproducible workflows that fit the molecule, the project goals, and the requirements for later technology transfer.
We support both the development of new processes and the optimization of existing ones, combining bioprocess engineering with analytical methods that help guide each development step.
Our process development services include:
- Upstream process development, including batch, fed-batch, intensified fed-batch, and perfusion processes for mammalian expression systems
- Downstream process development, including purification workflows designed to maintain product integrity and remove process-related impurities such as host cell proteins, DNA, and media components
- Bioprocess optimization and robustness testing to support scalability, reproducibility, and later transfer to pilot or production scale
- Development of process-supporting analytical methods to monitor product quality and critical process parameters throughout development
- Liquid formulation development and R&D stability studies to support product handling and long-term stability
All work is performed under FyoniBio’s ISO 9001-certified quality management system, supporting traceability and regulatory readiness.
FyoniBio provides in-depth structural characterization of biologics using high-resolution mass spectrometry. Our goal is to generate clear, reliable data that helps define critical quality attributes and supports confident decisions from early development through regulatory submission.
Using UPLC-QTOF-MS/MS and complementary analytical workflows, we analyze proteins, glycoproteins, oligonucleotides, and other complex biomolecules. Our expertise covers monoclonal antibodies, bispecifics, antibody-drug conjugates, fusion proteins, glyco-optimized biologics, and other recombinant proteins.
Our mass spectrometry analytics include:
- Biochemical protein characterization, including sequence confirmation, identification, and extensive PTM analysis
- IND/IMPD-ready characterization packages to support regulatory documentation
- Glycan analysis, including glycoprofiling, N-glycans, O-glycans, and site-specific glycosylation
- Analysis of product- and process-related impurities, including host cell proteins, host cell DNA, endotoxins, and other contaminants
- Stability-indicating analyses to support formulation and development decisions
- High-resolution analysis of complex biomolecules, including oligonucleotides
- Development of molecule-specific analytical workflows for complex or non-standard analytical questions
All work is performed under FyoniBio’s ISO 9001-certified quality management system, supporting traceability, reproducibility, and reliable documentation.
Functional & Potency Bioassays
FyoniBio develops and validates functional and potency bioassays that show how a therapeutic performs in a biological system. We support a broad range of drug types, including antibodies, fusion proteins, oligonucleotides, small molecules, and other complex biologics.
Our assays are designed to measure biological activity, mechanism of action, target engagement, and potency in scientifically relevant systems. Depending on the project, we work with non-cellular assay formats, immortalized cell lines, primary human immune cells, disease-relevant models, custom cell lines, and 3D cell models.
Our functional and potency bioassay services include:
- Binding and affinity assays, including biolayer interferometry, DRX2, ELISA, and ECLIA-based formats
- Cell-based functional assays, including signaling pathway analysis, apoptosis, cytotoxicity, ADCC, CDC, and immuno-oncology assays
- Potency assay development, including customer-specific assays for ADCC, neutralization, and Fc receptor binding
- Multiplex cytokine analysis for preclinical and clinical samples
- Molecular biology readouts, including genotyping, SNP analysis, qRT-PCR, gene expression, and protein expression
- Flow cytometry-based assays, including multicolor FACS analysis for immune cell characterization and functional readouts
- Development of monoclonal and polyclonal antibodies for bioanalytical applications in cooperation with a local partner
All assays are developed and validated under FyoniBio’s ISO 9001-certified systems, ensuring reproducibility, traceability, and alignment with regulatory expectations.
FyoniBio provides bioanalytical support for clinical development from early trials to late-stage studies. With more than 15 years of experience in clinical bioanalysis, we develop, validate, and run assays under GCLP to support the evaluation of pharmacokinetics, pharmacodynamics, immunogenicity, and patient-specific biomarkers.
Our team supports clinical studies from Phase I to Phase IV, working with a wide range of therapeutic formats — from oligonucleotides to recombinant proteins, bispecific antibodies, fusion proteins, and antibody-drug conjugates. Each method is developed with the study objectives in mind, helping generate reliable clinical data that can stand up to scientific and regulatory review.
Our clinical bioanalysis services include:
- Assay development and validation for clinical sample analysis under GCLP
- PK and PD assessment of biotherapeutics and other complex therapeutic formats
- Immunogenicity testing, including ADA assays and related confirmatory workflows
- Bioanalysis of clinical samples, including sample handling, storage, and analysis
- SNP analysis and molecular biology-based readouts
- Immunomonitoring, including immune phenotyping, cytokine release testing, and functional immune cell assays
- Central laboratory and sample management for clinical studies
- Custom monoclonal and polyclonal antibody generation for bioanalytical applications in collaboration with BioGenes
Our analytical toolbox includes ELISA, electrochemiluminescence-based assays, LC-MS/MS, flow cytometry, and cellular and molecular assays. All work is performed under GCLP conditions and FyoniBio’s ISO 9001-certified quality management system, supporting traceability, reproducibility, and compliance with relevant ICH, FDA, and EMA expectations.