FyoniBio

What FyoniBio does

FyoniBio GmbH is a Berlin, Germany-based contract development and manufacturing organization (CDMO) founded in early 2022 as a spin-off from Glycotope's service unit. It provides fee-for-service biologics development across four integrated service lines: cell line development, process development, mass spectrometry analytics, and GCLP-compliant clinical bioanalysis, supporting biotech and pharmaceutical clients on monoclonal antibodies, bispecifics, fusion proteins, biosimilars, ADCs, and complex glycoproteins.

Its core technology is anchored in three proprietary mammalian cell line platforms - GlycoExpress® (engineered human cell lines producing authentic human post-translational modifications with titers up to 30 g/L in perfusion), CHOnamite® (CHO-K1, CHO-GS-KO and CHO-DG44 hosts achieving 8-12 g/L fed-batch titers), and CHOFlow® (FUT8 knock-out CHO for afucosylated ADCC-enhanced antibodies) - complemented by Waters UPLC / Bruker QTOF mass spectrometry infrastructure, the GlycoFiler® glycan-identification software, and ISO 9001:2015 and GCLP quality systems recognized by FDA, EMA, PEI and BfArM.

FyoniBio operates a B2B project-based professional services revenue model priced per engagement, with royalty-free cell-line licensing bundled into project packages. Customers are sourced primarily through direct scientific outreach, an aggressive conference circuit (BIO-Europe, PEGS Boston, Swiss Biotech Day, ESACT, Bioprocessing Summit Europe, CDMO Live, etc.), and listings on Scientist.com and ScienceExchange marketplaces. The company reports having supported over 100 biologics projects and completed over 40 GMP production runs, with expansion signaled through partnerships with INITS (integrated R&D-to-GMP pathway, 2025), PAM Theragnostics (Alzheimer's, 2026), and Propanc Biopharma (clinical PK assay, 2026), as well as the BioLamina / Alder Therapeutics cell-therapy consortium (2024).

Name

FyoniBio

Legal name

FyoniBio GmbH

Website

https://fyonibio.com

Company type

Private

Founded year

2022

Operating status

Operating

Headcount range

11–50 employees

Short description

FyoniBio GmbH is a Berlin-based biologics CDMO spun out of Glycotope in 2022, offering cell line development (GlycoExpress, CHOnamite, CHOFlow), process development, mass spectrometry analytics, and GCLP-compliant clinical bioanalysis to biotech and pharmaceutical clients worldwide.

Ownership category

akta.pro rank

Product category

Biologics Contract Development and Manufacturing Services (CDMO)

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Scientific Research and Development Services (5417), Medical and Diagnostic Laboratories (6215)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Biologics (mAbs/Recombinant Proteins) CDMO (HLAGABAC)

akta.pro secondary industry

Drug Substance–Drug Product Integrated CDMO (HLAGABAG)

Keywords

• Cell line development
• Biologics CDMO services
• Mass spectrometry analytics
• Clinical bioanalysis
• Bioprocess development

Headquarters

HQ city

Berlin

HQ country

Germany

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Contract Development Services: FyoniBio operates as a fee-for-service CDMO, providing project-based contract services for biopharmaceutical development. Services include cell line development, process development, analytical characterization, and clinical bioanalysis. Revenue is generated through project fees, typically structured as milestone-based payments or per-project contracts. The company serves biotech and pharma clients on a project basis with flexible engagement models ranging from standalone services to integrated development programs.
2. Cell Line Licensing: FyoniBio offers royalty-free licensing for their proprietary cell lines (CHOnamite®, CHOFlow®, GlycoExpress®), providing commercial freedom to clients without ongoing licensing fees. This is offered as part of integrated service packages rather than standalone licensing revenue.

Go-to-market motion2 records

Distribution channels4 records

Marketing channels6 records

Core offering

FyoniBio is a Berlin-based biopharmaceutical contract development organization (CDMO) providing integrated biologics development services for biotech and pharma clients worldwide. Its core offerings span cell line development on three proprietary platforms (GlycoExpress® human, CHOnamite® CHO, CHOFlow® afucosylated), upstream and downstream process development, mass spectrometry-based analytical characterization, GCLP-compliant clinical bioanalysis (PK, PD, immunogenicity), and functional/potency bioassays — delivered under ISO 9001:2015 quality systems aligned with ICH, FDA, and EMA guidelines.

Product overview

FyoniBio is a German biopharmaceutical services company offering an integrated biologics development platform spanning cell line development, process development, analytical characterization, and clinical bioanalysis. Its cell line development portfolio comprises three distinct platforms: GlycoExpress® (GEX®), a proprietary human cell line platform for glyco-optimized biologics with authentic human PTMs; CHOnamite®, a versatile CHO platform (CHO-K1, CHO-GS-KO, CHO-DG44) for high-yield production of complex proteins; and CHOFlow®, a glycoengineered CHO FUT8 knock-out platform for afucosylated ADCC-enhanced antibodies. These cell line platforms are complemented by integrated Process Development (upstream and downstream), Mass Spectrometry Analytics (intact mass, peptide mapping, glycan profiling via Waters/Bruker QTOF systems), Clinical Bioanalysis (GCLP/ISO 9001 PK, PD, and immunogenicity testing), Functional and Potency Bioassays, and Bioanalytical Characterization services. All offerings are ISO 9001:2015 certified and conducted under GCLP-compliant, ICH/FDA/EMA-aligned quality systems. The company was founded in 2022 as a spin-off from Glycotope and is headquartered in Berlin, Germany.

Differentiator

Problem solved

Functional benefit

Brands

• GlycoExpress® (GEX®): Human cell line platform for production of glyco-optimized biopharmaceuticals with authentic human post-translational modifications
• CHOnamite®
• CHOFlow®
• GlycoFiler®

Products and services

• GlycoExpress® (GEX®) GlycoExpress® (GEX®) is a proprietary human cell line platform engineered for the screening and production of glyco-optimized biotherapeutics with authentic human post-translational modifications. Features a toolbox of glycoengineered human cell lines enabling precise control over sialylation, fucosylation, bisecting GlcNAc, and mannose-6-phosphate levels. Achieves up to 30 g/L in perfusion for IgGs and supports complex proteins including IgA, blood factors, hormones, fusion proteins, and enzymes. Targeted at biotech and pharma developing difficult-to-express glycoproteins and protein therapeutics where authentic human glycosylation is critical for function, stability, or reduced immunogenicity.
• CHOnamite® CHOnamite® is a versatile CHO production cell line platform offering CHO-K1, CHO-GS-KO, and CHO-DG44 host cell lines engineered for high-yield expression up to 12 g/L using advanced transposase technology. Supports bispecific antibodies, biosimilars, and difficult-to-express proteins with robust fed-batch processes, early CQA analysis, and royalty-free licensing integrated into service packages. Targets biotech and pharma clients developing monoclonal antibodies, bispecifics, and biosimilars with a need for high-yield commercial cell lines.
• CHOFlow® CHOFlow® is a proprietary glycoengineered CHO cell line with FUT8 knock-out built on the CHOnamite® host, designed for high-yield production of afucosylated monoclonal antibodies and glycoproteins with enhanced ADCC activity. Achieves >5 g/L in fed-batch, maintains genetic stability over >70 population doublings, and provides up to 10x increased FcγRIIIa binding affinity for improved NK cell-mediated cytotoxicity. Targeted at immuno-oncology developers and antibody therapeutics companies seeking consistent afucosylated antibody production for cancer, infectious disease, and autoimmune therapy programs.
• Process Development Integrated upstream (USP) and downstream (DSP) process development services leveraging mammalian cell culture systems (GlycoExpress®, CHOnamite®) with flexible process modes including batch, fed-batch, intensified fed-batch, and perfusion. Covers clone screening, process optimization, chromatographic purification, formulation development, and tech transfer to GMP partners. Scalable from 10 mL to 1000 L bioreactors. Targets biotech and pharma clients needing scalable, GMP-transferable processes for monoclonal antibodies, bispecifics, fusion proteins, and complex glycoproteins.
• Mass Spectrometry Analytics In-depth mass spectrometry characterization of biotherapeutics using bottom-up, middle-up, and top-down proteomics approaches. Services include intact mass analysis, peptide mapping, post-translational modification assessment, disulfide bond analysis, ADC drug-to-antibody ratio (DAR) determination, and comprehensive N-glycan and O-glycan profiling. Utilizes Waters Acquity UPLC systems coupled with Bruker Impact HD/II QTOF and Compact QTOF instruments. Supported by the proprietary GlycoFiler® software for automated glycan identification. Targeted at biopharma clients needing detailed structural and glycoform characterization of complex biologics.
• Clinical Bioanalysis GCLP-compliant, ISO 9001-certified bioanalytical services for clinical trials (Phase I–IV) covering pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity (ADA, neutralizing antibody) testing for biotherapeutics ranging from small oligonucleotides to large proteins. Capabilities include ligand binding assays (ELISA, ECLIA/MSD), LC-MS/MS-based PK, flow cytometry, and cytokine release assays. Analysis capacity of up to 10,000 samples per year under ICH, FDA, and EMA guidelines. Serves biopharma companies requiring regulatory-compliant clinical trial sample analysis.
• Functional and Potency Bioassays Custom-tailored functional and potency bioassays measuring the biological activity of biotherapeutics across non-cellular and cell-based formats. Portfolio includes binding assays, cell viability/cytotoxicity assays (ADCC, CDC), immuno-oncology assays, signaling assays, and specialized coagulation and enzymatic activity assays. Applicable to oncology, rheumatology, immunology, hematology, endocrinology, and enzyme replacement therapy. Targeted at biopharma clients developing therapeutic proteins, antibodies, and cell-based therapies requiring mechanistic and regulatory-grade potency data.
• Bioanalytical Characterization Comprehensive analytical characterization services spanning biochemical analytics (SEC, WCX/WAX, RP, HIC, ELISA, Western Blot, IEF, DLS), mass spectrometry, and functional potency assessments. Supports monoclonal antibodies, bispecifics, ADCs, fusion proteins, biosimilars, oligonucleotides, glycoproteins, blood factors, hormones, and radiopharmaceuticals from feasibility studies through regulatory submissions under ISO 9001 and ICH/FDA/EMA guidelines. Targeted at biopharma clients needing integrated analytical packages across modalities and program stages.

Quantifiable outcome

• 40+ GMP production runs completed successfully with global regulatory acceptance
• +5 more outcomes

Named customers11 records

Segments5 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration3 records

Feature6 records

Partnerships

Nine partnerships are on record, tiered core, strategic and completed.

• PAM TheragnosticscoreStrategic or Co-development Partner · 2 June 2026Collaboration to establish a production process for PAM Theragnostics' lead compound peptidylglycine alpha-amidating monooxygenase (PAM), a complex glycoprotein being developed for prevention of Alzheimer's disease.
• Propanc BiopharmacoreStrategic or Co-development Partner · 25 March 2026Service agreement to establish and validate an LC-MS-based pharmacokinetics assay for Propanc's lead product candidate PRP, supporting their upcoming Phase 1b First-in-Human study in patients with advanced solid tumors.
• INITScoreStrategic or Co-development Partner · 22 October 2025Strategic partnership to provide biotech companies with a fully integrated solution from R&D to GMP clinical production. Combines FyoniBio's cell line and process development expertise with INITS' upcoming SMO and GMP production facilities.
• BioLaminastrategicStrategic or Co-development Partner · 20 March 2024Consortium grant agreement to propel recombinant human laminin development for clinical applications. Combined expertise in complex protein production, laminin-based cell culture, and stem cell therapy development.
• Alder TherapeuticsstrategicStrategic or Co-development Partner · 20 March 2024Consortium grant agreement alongside BioLamina for recombinant human laminin development for clinical applications, supporting allogeneic cell therapy manufacturing.
• Strike PharmacompletedStrategic or Co-development Partner · 16 May 2023Successfully concluded cell line development cooperation for Strike Pharma's bi-specific antibody clinical candidate. Final production clone achieved high titer and robust stability, enabling clinical manufacturing.
• adivo GmbHcoreStrategic or Co-development Partner · 10 January 2023Service agreement covering generation of production cell line for adivo's canine therapeutic mAb candidate to support first-in-animal studies, leveraging CHOnamite platform.
• ProteoNicstrategicTechnology or Integration · 27 June 2022Licensing agreement for ProteoNic's premium 2G UNic expression technology platform for production of biologics. Expands cell line development options and helps reduce production costs for complex or hard-to-produce biologics.
• BioGenescoreTechnology or IntegrationPartnership for custom generation of monoclonal and polyclonal antibodies supporting bioanalytical assays. Complements FyoniBio's clinical bioanalysis services with tailored antibody reagents for PK, ADA, and biomarker assays.

Scale indicators7 records

Recent moves7 records

Expansion highlights6 records

Broad incumbents

• Samsung Biologics: Large-scale Korean-headquartered biologics CDMO with end-to-end cell line, process, and GMP services competing for the same biologics development programs as FyoniBio at a much larger scale.
• Lonza Biologics: World's largest biologics CDMO offering end-to-end cell line, process, analytical, and large-scale GMP services — a broad incumbent that competes with FyoniBio for higher-value and larger-scale engagements.

Direct peers

• KBI Biopharma: US-based biologics CDMO offering cell line development, process development, analytical services, and GMP manufacturing — comparable to FyoniBio's integrated biologics development platform.
• Rentschler Biopharma: German-based mid-sized biologics CDMO with cell line development, process development, and GMP manufacturing, comparable to FyoniBio in European specialty biologics services.
• AGC Biologics: Global CDMO providing cell line development, process development, and GMP manufacturing for biologics including mAbs and recombinant proteins — directly comparable to FyoniBio's core service stack.
• Celonic: Germany/Europe-headquartered biologics CDMO offering cell line development, process development, and GMP manufacturing with proprietary CHO expression platforms — competing head-to-head with FyoniBio in the European biologics CDMO market.
• ProBioGen: Berlin-based biologics CDMO specializing in cell line engineering (e.g., CHO-based platforms) and GMP manufacturing, with glyco-engineering and process development capabilities directly comparable to FyoniBio's CHO and GlycoExpress offerings.
• Eurofins Bioanalytical Services: Global bioanalytical and bioassay services provider covering PK, immunogenicity, and biopharmaceutical characterization comparable to FyoniBio's Clinical Bioanalysis and Mass Spectrometry service lines.

Emerging players

• ProteoNic: Niche provider of premium expression technology platforms (e.g., 2G UNic) for biologics production — comparable to FyoniBio in the cell line technology stack and is a disclosed licensor/partner.
• BioGenes (specialty bioanalytical): Berlin-based specialist in immunoassay and antibody reagent development for bioanalytical applications — overlaps with FyoniBio's clinical bioanalysis work and is listed as a collaboration partner.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks1 record

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/fyonibio

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about FyoniBio