Biogenes

What Biogenes does

BioGenes GmbH is a Berlin-based specialty contract research organization founded in 1992 by Dr. Alexander Knoll and Dr. Sergej Ovodov, providing custom antibody development and immunoassay services to the biopharmaceutical, biotechnology, diagnostics, and research sectors across more than 40 countries. The company employs approximately 70 specialists (70 dedicated specialists across antibody development, HCP analytics, QA, and project management) and has completed over 10,000 antibody projects and 400+ assay projects since founding, serving a base of more than 5,000 customers including most of the Top 10 global pharma companies, with a stated 80%+ customer return rate.

The company's core technology platform spans polyclonal and monoclonal antibody generation, 2D PAGE, 2D Western Blot, 2D DIGE, immunoaffinity chromatography (IAC), LC-MS/MS, hybridoma/Sanger sequencing, and immunoassay development across ELISA, chemiluminescent (CLIA), and fluorescent (FIA) formats. BioGenes' centerpiece commercial offering is host cell protein (HCP) analytics, including its proprietary BioGenes 360 approach that delivers four differentiated kit types per cell line (CHO and E.coli) plus coverage of HEK293 — combined with a recently launched portfolio of high-risk HCP kits targeting PLBL2 (LOD 0.015 ng/mL), PRDX1 (~0.04 ng/mL), and CTSB (~0.039 ng/mL). Operations are ISO 9001:2015 certified since 1999, and the company holds OLAW Assurance #A5755-01 enabling US federally funded research. Contract manufacturing capacity has been expanded to up to 3,000 assay plates per week.

BioGenes operates a sales-led, project-based professional services model: custom antibody and assay development projects are scoped through direct consultations, quote-based pricing, and ISO 9001:2015-compliant delivery with full customer ownership of results and reagents; the business is supplemented by catalog sales of generic and high-risk HCP ELISA kits through an online shop and a global distributor network. The company filed no public revenue disclosure and is privately held with concentrated founder ownership under Drs. Knoll and Ovodov.

Name

Biogenes

Legal name

BioGenes GmbH

Website

https://biogenes.de

Company type

Private

Founded year

1992

Operating status

Operating

Headcount range

51–100 employees

Short description

BioGenes is a Berlin-based specialty CRO providing custom antibody and immunoassay (ELISA, CLIA, FIA) development plus HCP analytics for biopharma, biotech, diagnostics, and research customers across 40+ countries, with proprietary HCP kits and 30+ years of regulatory-grade experience.

Ownership category

akta.pro rank

Product category

Custom Antibody & Immunoassay Development Services

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), In-Vitro Diagnostic Substance Manufacturing (325413), Biological Product (except Diagnostic) Manufacturing (325414)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071)

akta.pro primary industry

Antibody Discovery & Engineering Platforms (display tech, bispecifics, Fc engineering) (HLAAAIAB)

akta.pro secondary industry

Protein Interaction & Structural Biology Platforms (cryo-EM, X-ray, NMR, biophysics) (HLAAAIAH)

Keywords

• Custom antibody development
• Immunoassay development
• Host cell protein analytics
• HCP ELISA kits
• Biopharmaceutical assay services

Headquarters

HQ city

Berlin

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Custom Antibody Development Services: Custom development of monoclonal and polyclonal antibodies tailored to customer-specific antigens and applications. Services include immunization, antibody generation, characterization, and purification. Projects are bespoke and contracted individually with full customer ownership of results and reagents.
2. Custom Immunoassay Development & Contract Manufacturing: End-to-end custom immunoassay development and contract manufacturing in ELISA, CLIA, and FIA formats. Manufacturing capacity of up to 3,000 assay plates per week. Minimum 50 kits per order. Revenue is project-based with full documentation, CoA per batch, and ISO 9001:2015 compliant production.
3. Generic HCP ELISA Kit Sales: Sale of catalog ELISA kits for CHO, E.coli, and HEK293 host cell proteins. CHO 360 HCP ELISA kits (Type A-D), E.coli 360 HCP ELISA kits (Type A-E), and HEK293 HCP ELISA kits. Kits are also sold through distributor networks. Also includes high-risk HCP kits (PLBL2, PRDX1, CTSB).
4. Analytical Services: HCP analytics including 2D PAGE, 2D Western Blot, 2D DIGE, IAC coverage analysis, and MS-based protein identification. These services are offered independently or in combination with antibody development projects.
5. Pharmacokinetic and Immunogenicity Assay Services: PK and immunogenicity assay development and testing services often delivered in partnership with FyoniBio for preclinical and clinical sample analysis.

Pricing tiers

Go-to-market motion1 record

Distribution channels4 records

Marketing channels8 records

Core offering

BioGenes develops custom monoclonal, polyclonal, anti-idiotypic, and recombinant antibodies and provides full custom immunoassay (ELISA, CLIA, FIA) development and contract manufacturing. Its specialty is Host Cell Protein (HCP) analytics for biopharmaceutical quality control, offering proprietary multi-kit BioGenes 360 generic ELISA platforms for CHO, E. coli, and HEK293 cell lines, high-risk HCP kits (PLBL2, PRDX1, CTSB), and orthogonal coverage methods such as IAC + 2D DIGE and LC-MS/MS, supplemented by pharmacokinetic, immunogenicity, and analytical services.

Product overview

BioGenes is a full-service provider of customized immunoassays and antibody development services for the biopharmaceutical and diagnostics industry. The portfolio centers on HCP (Host Cell Protein) analytics, including custom and generic ELISA kits for CHO, E. coli, and HEK293 cell lines, plus specialized high-risk HCP kits for CHO PLBL2, PRDX1, and CTSB. Supporting services include custom monoclonal and polyclonal antibody development, pharmacokinetic and immunogenicity assays, peptide synthesis, hybridoma/antibody sequencing, analytical services (2D DIGE, 2D Western Blot, IAC-MS), and contract immunoassay manufacturing. The company operates ISO 9001:2015 certified operations with over 30 years of experience serving global pharmaceutical clients.

Differentiator

Problem solved

Functional benefit

Brands

• BioGenes 360: Enhanced generic HCP ELISA approach using multiple kit types with different antibody compositions for CHO and E.coli cell lines.
• BlueCap Buffers

Products and services

• Custom Monoclonal Antibody Development Custom monoclonal antibody generation services using hybridoma technology in mice, including pair search and antibody modification, intended for biopharmaceutical, diagnostic, and research customers needing highly specific monoclonal reagents.
• Custom Polyclonal Antibody Development Custom polyclonal antibody generation in rabbits, mice, goats, or sheep, with optimized immunization protocols and affinity purification to deliver high specificity, high sensitivity, and high titers for biopharmaceutical, diagnostics, and research customers.
• Anti-Idiotypic Antibody Development Custom anti-idiotypic antibody development using dual-step affinity chromatography to isolate specific anti-idiotypic antibodies while depleting human IgGs, supporting immunogenicity testing and anti-drug antibody (ADA) detection in biopharmaceutical applications.
• Recombinant Antibody Services Recombinant antibody services enabling transition from hybridoma to recombinant antibody formats, offering high reproducibility, long-term stability, and precise antibody engineering (isotype switching, chimerization, humanization) for biopharmaceutical and diagnostics customers.
• Custom HCP ELISA Development Custom Host Cell Protein (HCP) ELISA development service for process-specific HCP monitoring, including mock antigen preparation, antibody generation, assay development, qualification, and pre-validation for biopharmaceutical manufacturing customers.
• BioGenes 360 CHO HCP ELISA Kits Generic Host Cell Protein ELISA kits for CHO cell lines using the proprietary BioGenes 360 approach with four kit types (CHO|360-HCP ELISA A/B/C/D), each using different sets of anti-HCP antibodies generated from different animal species and antigen preparations, enabling direct comparison of antibody compositions to select the best panel.
• BioGenes 360 E. coli HCP ELISA Kits Generic Host Cell Protein ELISA kits for E. coli cell lines as part of the BioGenes 360 platform, including four kit types (Type A 2G, Type C, Type D 2G, Type E) using different cell lines and growth media combinations to improve coverage of E. coli-derived impurities.
• HEK293 HCP ELISA Kits (HEK293|360) Generic Host Cell Protein ELISA kits for HEK293 cell lines (HEK293|360 HCP ELISA) covering a broader spectrum of HEK293 host cell proteins than other commercially available generic HCP assays.
• CHO PLBL2 ELISA Kit ELISA kit for ultra-sensitive detection and quantification of phospholipase B-like 2 (PLBL2), a high-risk host cell protein with significant immunogenic potential in CHO-based biotherapeutics. LOD 0.015 ng/mL, working range 0.078-5 ng/mL, CHO antigen expressed in HEK293 cells to minimize cross-reactivity.
• CHO PRDX1 ELISA Kit ELISA kit for targeted monitoring of Peroxiredoxin-1 (PRDX1), a high-risk HCP due to its immunogenic potential and redox activity, with LOD ~0.04 ng/mL, LOQ ~0.15 ng/mL, and ICH Q2-compliant validation using CHO-specific polyclonal antibodies.
• CHO CTSB ELISA Kit Ultra-sensitive ELISA kit for detection of Cathepsin B (CTSB), a high-risk lysosomal cysteine protease in CHO-based biopharmaceutical manufacturing, with LOD ~0.039 ng/mL, working range 0.3125-20 ng/mL, ICH Q2-compliant validation, polyclonal antibodies, and minimal cross-reactivity.
• Pharmacokinetic (PK) Assay Development Custom pharmacokinetic assay development services for the measurement of therapeutic antibodies and proteins in preclinical and clinical samples, delivered alongside partner FyoniBio for bioanalytical support.
• Immunogenicity Assay Development Custom assay development services for the detection of anti-drug antibodies (ADA) and neutralizing antibodies (NAb) in biopharmaceutical development and clinical sample analysis.
• IVD Application Antibodies Custom in vitro diagnostic antibody products and services for assays such as PCR, ELISA, CLIA, lateral flow, and immunohistochemistry, supporting diagnostics manufacturers with high-quality, customizable antibody reagents.
• Anti-Oligonucleotide Antibody Development Custom anti-oligonucleotide antibodies specifically developed for the detection and quantification of oligonucleotides in diagnostics and research applications.
• ELISA / Immunoassay Production Service Contract manufacturing of custom immunoassays including ELISA, Chemiluminescent Immunoassay (CLIA), and Fluorescent Immunoassay (FIA) in kit or component formats, under ISO 9001:2015 with capacity up to 3,000 assay plates per week and full documentation/CoA per batch.
• Hybridoma / Antibody Sequencing Sanger-based variable region antibody gene sequencing (VH/VL) using RACE technology, enabling validation, chimerization/humanization, and intellectual property protection of monoclonal antibodies independent of forward primer sets.
• HCP Analytical Services (2D PAGE, 2D Western Blot, 2D DIGE, IAC, MS) Orthogonal analytical services for HCP coverage analysis, including 2D PAGE, 2D Western Blot, 2D DIGE (including immunoaffinity chromatography coupled 2D DIGE for near-native conditions), IAC, and mass spectrometry-based protein identification, offered independently or in combination with antibody development projects.
• Non-Clinical Immunization Studies Preclinical in vivo immunization studies in mice, rats, or rabbits, including efficacy, PK/PD, toxicity, dose-finding, and challenge studies, supporting vaccine and biologic development programs for pharmaceutical and biotech customers.
• Custom Peptide Synthesis Services Custom peptide synthesis services including epitope prediction, automated solid-phase synthesis, modification, and fluorescent labeling, delivered in partnership with BIOSYNTAN GmbH to support antibody generation projects.

Quantifiable outcome

• 10,000+ antibody projects and 400+ assay projects completed since 1992
• +3 more outcomes

Named customers9 records

Segments4 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Five partnerships are on record, tiered core and supporting.

• Eleva GmbHcoreStrategic or Co-development Partner · 1 January 2025BioGenes has collaborated with Eleva GmbH since 2011 on HCP ELISA assay development for Eleva's moss-based (Physcomitrium patens) expression platform. BioGenes developed the first customary HCP ELISA assay for this platform and continues to support Eleva in developing specific antibodies and immunoassays. The collaboration has included process-specific assay development, orthogonal method validation, and support for CPV-104 (recombinant complement factor H) production, achieving 77% HCP coverage with new assays.
• FyoniBiocoreStrategic or Co-development PartnerFyoniBio is a strategic partner offering ISO 9001:2015 certified biopharmaceutical services specializing in PK, biomarkers, immunogenicity assays, and complex bioassays for (pre-)clinical sample analysis under GCLP conditions. BioGenes and FyoniBio collaborate on pharmacokinetic assays and immunogenicity assay development, with BioGenes generating antibodies and FyoniBio setting up and validating assays. Both companies jointly published on establishing immunogenicity assays for therapeutic antisense oligonucleotides.
• Alphalyse A/ScoreTechnology or IntegrationAlphalyse is a CRO and protein analysis lab specializing in mass spectrometry-based impurity analysis and analytical protein characterization. BioGenes cooperates with Alphalyse for analytical HCP services, specifically LC-MS/MS analysis for HCP coverage determination. Alphalyse's MS capabilities complement BioGenes' antibody-based methods for orthogonal HCP analysis.
• trenzyme GmbHsupportingStrategic or Co-development Partnertrenzyme is a privately owned German CRO offering cell line development, iPSC differentiation, and recombinant protein production services. BioGenes partners with trenzyme for protein production services, enabling customers to access complementary recombinant protein capabilities alongside BioGenes' antibody and assay development services.
• BIOSYNTAN GmbHsupportingStrategic or Co-development PartnerBIOSYNTAN is a German specialist in custom peptide synthesis including linear and cyclic peptides with unusual residues and modifications. BioGenes partners with BIOSYNTAN for peptide synthesis services, which are offered as part of BioGenes' antibody development service portfolio to support customers needing peptide antigens or modified peptides for antibody generation.

Scale indicators7 records

Recent moves6 records

Expansion highlights6 records

Regional players

• Aldevron: Aldevron is a US-based biopharmaceutical services company offering custom antibody and protein production — comparable custom services for biologics developers, but with stronger US geographic focus than BioGenes.
• Syngene International: Syngene is an India-based CRO/CDMO providing custom antibody generation and bioanalytical services for global biopharma — comparable service offering with cost-arbitrage positioning, primarily competing in different geographies but addressing the same customer use cases.

Direct peers

• GenScript: GenScript provides custom monoclonal/polyclonal antibody generation, recombinant antibody services, and immunoassay development globally — directly comparable to BioGenes' custom antibody and immunoassay development services.
• Cygnus Technologies (part of Maravai LifeSciences): Cygnus Technologies is the most direct competitor in generic and process-specific HCP ELISA kits (CHO, E.coli, HEK293) and HCP coverage analysis for biopharmaceutical manufacturing — overlapping heavily with BioGenes' core franchise.
• Rockland Immunochemicals: Rockland Immunochemicals offers custom polyclonal and monoclonal antibody development and immunoassay reagents — a closely comparable specialty CRO/reagent provider serving similar biopharma and diagnostics customers.

Broad incumbents

• Abcam (Danaher): Abcam (now part of Danaher) is a global antibody reagent company offering both catalog and custom antibodies plus immunoassay tools, competing with BioGenes in antibody supply for diagnostics and research.
• Eurofins Scientific: Eurofins operates a global biopharma product testing network including HCP and impurity analytics; it competes with BioGenes' analytical services business at the larger end of the enterprise customer base.
• Bio-Techne: Bio-Techne (including R&D Systems, ProteinSimple, and ExoDx) is a large, diversified life science reagent and assay company offering antibodies, ELISA kits, and analytical tools — a broader incumbent competing with BioGenes in antibody reagents and immunoassays.
• Cell Signaling Technology (CST): CST is a leading antibody and immunoassay reagent company known for high-quality, validation-heavy antibody products — a broader incumbent competing for premium antibody share in pharma and diagnostics.
• Lonza Bioanalytics: Lonza offers large-scale bioanalytical and bioprocess testing services including HCP analytics as part of its broader CDMO portfolio, providing competitive pressure on enterprise-level immunoassay and analytical contracts.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/biogenes-gmbh
• Xx.com/biogenesservice

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 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 Biogenes