Richter-Helm

What Richter-Helm does

Richter BioLogics GmbH (formerly Richter-Helm BioLogics), headquartered in Hamburg, Germany, is a contract development and manufacturing organization (CDMO) wholly owned by Hungarian pharmaceutical group Gedeon Richter Plc since 2024. Founded in 1987 as one of Germany's first recombinant protein manufacturers, the company specializes in microbial-derived biopharmaceuticals produced in E. coli and Pichia pastoris expression systems. It operates two cGMP-compliant multiproduct manufacturing facilities in Bovenau, Germany, totaling 10,000 m², with fermenter volumes ranging from 300L to 1,500L and a GMP-certified P2 facility added in 2025.

The company's service portfolio spans the full development-to-commercial lifecycle, including strain and fermentation development, downstream processing, process characterization, GMP-compliant analytics, and drug substance manufacturing. Its proprietary pART plasmid DNA production platform delivers ≥95% purity and ≥98% supercoiled isoform pDNA, scalable from 10L to 1,000L fermentation. Product classes include recombinant proteins and peptides, VHH/Nanobodies and Fab fragments, plasmid DNA, and bacterial vaccines. Facilities are approved by EMA, FDA, PMDA, ANVISA, MFDS, Health Canada, and Chinese authorities, with an EMA ATMP certification granted in May 2019 and a 2026 FDA inspection returning zero findings.

Richter BioLogics generates revenue through negotiated, project-based CDMO contracts covering process development, GMP manufacturing, and analytical services for clinical phases I–III and commercial supply. Its customer base spans large pharmaceutical companies, small- and mid-size pharma, and biotech firms worldwide, with anchor relationships including INOVIO Pharmaceuticals (since 2014, including COVID-19 DNA vaccine manufacturing) and Nykode Therapeutics. The business development function is sales-led, supported by a 'Person in Plant' project management model and active participation in BIO Convention, Nordic Life Science Days, and CPhI.

Name

Richter-Helm

Legal name

Richter BioLogics GmbH

Website

https://richterbiologics.eu

Company type

Private

Founded year

1987

Operating status

Operating

Headcount range

251–500 employees

Short description

Richter BioLogics is a German contract development and manufacturing organization (CDMO) specializing in microbial-derived biopharmaceuticals, serving global large pharma, mid-size pharma, and biotech clients with E. coli and Pichia-based recombinant proteins, plasmid DNA, antibodies, and bacterial vaccines.

Ownership category

akta.pro rank

Product category

Biopharmaceutical Contract Development and Manufacturing (CDMO)

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Services-Commercial Physical & Biological Research (8731), Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

mRNA/LNP & Nucleic Acid Therapeutics CDMO (HLAGABAF)

akta.pro secondary industries

Plasmid DNA & mRNA Manufacturing Services (HLAAAKAE), Gene Therapy (Viral Vector/Plasmid) CDMO (HLAGABAE), mRNA & Nucleic Acid Manufacturing Services (mRNA/saRNA/Plasmid DNA) (HLAGAGAC)

Keywords

• Microbial biopharmaceutical manufacturing
• Contract development manufacturing
• Plasmid DNA production
• E. coli fermentation services
• GMP biologics manufacturing

Headquarters

HQ city

Hamburg

HQ country

Germany

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Contract Development and Manufacturing Services (CDMO): Richter BioLogics is a 100% CDMO providing outsourced services to pharmaceutical and biotech companies for drug development and manufacturing. Services span from development to scalable manufacturing across clinical phases I–III and commercial supply. Revenue is generated through project-based contracts for process development, GMP manufacturing, and analytical services.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels4 records

Core offering

Richter BioLogics is a biopharmaceutical contract development and manufacturing organization (CDMO) that develops and produces microbial-derived biopharmaceuticals—including recombinant proteins, peptides, antibodies (VHH/Nanobodies, Fab fragments), plasmid DNA, and bacterial vaccines—from bacterial (E. coli) and yeast (Pichia pastoris) expression systems. It offers end-to-end services from strain and process development through GMP drug substance manufacturing, supported by in-house analytics, a proprietary pART plasmid DNA platform, and two cGMP-compliant facilities (fermenter volumes 300L to 1,500L) in Bovenau, Germany.

Product overview

Richter BioLogics is a leading biopharmaceutical CDMO specializing in microbial-derived products (bacteria and yeasts) with over 35 years of experience. The company offers an integrated service portfolio spanning Process Development (strain/fermentation development, downstream processing, process characterization), Analytics (GMP and development services with full method spectrum), and GMP-compliant Drug Substance Manufacturing. Core product capabilities include pDNA manufacturing via the proprietary pART platform, recombinant proteins/peptides, antibodies (VHH/Nanobodies, Fab fragments), and bacterial vaccines. The company operates two multiproduct GMP facilities in Bovenau, Germany with fermenter volumes from 300L to 1500L, serving clients from early clinical phases through commercial supply. Services include end-to-end project management with dedicated teams ensuring quality, flexibility, and regulatory compliance across EMA, FDA, PMDA, ANVISA, and MFDS-approved facilities.

Differentiator

Problem solved

Functional benefit

Products and services

• Process Development Services Comprehensive process development including strain and fermentation development (E. coli and Pichia), downstream process development, and process characterization services for microbial-based biopharmaceuticals, for pharmaceutical and biotech clients from clinical to commercial scale.
• Analytics / Quality Control Services QC testing meeting client and regulatory body requirements, including GMP services, development services, and a broad spectrum of analytical methods for release testing of bulk API and products, for pharmaceutical and biotech customers.
• Drug Substance Manufacturing GMP-compliant manufacturing of microbial drug substances from bacteria (E. coli) and yeasts (Pichia pastoris) with fermenter volumes from 300L to 1,500L and full downstream processing capacity, spanning clinical phases I–III and commercial supply.
• pDNA (Plasmid DNA) Manufacturing Manufacturing of plasmid DNA using the proprietary pART platform, delivering highly purified supercoiled (sc) pDNA at ≥95% purity for cell and gene therapy, DNA vaccine, and mRNA therapeutic template applications, scalable from 10L to 1,000L fermentation volumes across two cGMP facilities.
• Recombinant Protein Manufacturing Production of recombinant proteins and peptides using bacterial (E. coli) and yeast (P. pastoris) expression systems, for pharmaceutical and biotech clients.
• Antibody Products (VHH/Nanobodies, Fab fragments) Manufacturing Manufacturing of single-domain antibodies (VHH/Nanobodies) and Fab fragments using microbial expression systems, serving the growing therapeutic demand for these antibody formats in biopharma.
• Bacterial Vaccines Manufacturing Contract manufacturing of bacterial vaccines using microbial production technology, for vaccine developers requiring GMP-compliant production.
• Quality Management Services Quality system meeting cGMP requirements of EMA, FDA, PMDA, ANVISA, MFDS, Health Canada, and other regulators, with a unified QMS covering training, document management, and deviation management that supports audit readiness and supply chain reliability for clients.

Quantifiable outcome

• Zero FDA inspection findings in 2026 — six-day inspection with four auditors examining all systems, batch records, and quality decisions.
• +5 more outcomes

Named customers8 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Seven partnerships are on record, tiered core, supporting and minor.

• INOVIO PharmaceuticalscoreStrategic or Co-development Partner · 30 April 2020Manufacturing partnership for INO-4800 COVID-19 DNA vaccine (Phase 2/3) and VGX-3100 DNA medicine (Phase 3). INOVIO has been working with Richter-Helm since 2014. The partnership was partially funded by CEPI ($1.3M grant). Richter-Helm manufactured DNA plasmids under GMP standards using VGXI technology license.
• Inovio Pharmaceuticals Inc.coreStrategic or Co-development Partner · 1 January 2020Collaboration for COVID-19 DNA vaccine INO-4800 manufacturing. Richter-Helm mobilized resources to ensure sufficient supply of late-stage clinical and commercial batches. Additional capacity significantly expanded manufacturing to meet urgent pandemic needs.
• Veeva (Quality Cloud)coreTechnology or IntegrationRichter BioLogics adopted Veeva Quality Cloud's external collaboration features to streamline quality processes with biopharma sponsors, replacing manual email-based communication with unified digital quality ecosystems. This enables reduced lead times, improved audit readiness, and simplified approval workflows.
• VGXI Inc. (GeneOne Life Science subsidiary)supportingTechnology or IntegrationLong-term partnership for technology transfer and scale-up of pDNA production processes. VGXI's manufacturing technology is licensed for use at Richter-Helm facilities. Shared partnership resulting in joint projects and project transfers for commercial supply.
• Nykode TherapeuticscoreStrategic or Co-development PartnerStrategic manufacturing partnership announced December 2022 for biopharmaceutical manufacturing. Nykode develops novel vaccines and immunotherapies.
• Gedeon Richter Plc (Parent Company)coreOthersGedeon Richter Plc (Hungary) acquired 100% ownership in 2024, becoming the sole owner. Previously a joint venture with HELM AG (50/50). Gedeon Richter also operates mammalian cell-based CDMO services in Budapest and Debrecen, Hungary, complementing Richter BioLogics' microbial focus.
• LiebherrminorOthersRichter Kran (an Austrian crane hire company) is a separate entity from Richter BioLogics. Mentioned in unrelated news about crane fleet expansion. No direct business relationship.

Scale indicators10 records

Recent moves18 records

Expansion highlights6 records

Direct peers

• Charles River Laboratories (Cobra Biologics): Charles River acquired Cobra Biologics, a specialist microbial and viral vector CDMO with pDNA manufacturing capabilities — directly comparable to Richter BioLogics in modality, scale range, and customer base of gene therapy and vaccine developers.
• AGC Biologics: Global CDMO offering both microbial and mammalian biopharmaceutical manufacturing, including pDNA and viral vector services. Closely comparable to Richter in CDMO services for biologics, with overlapping customer segments in pharma and biotech.
• Biovian: Finnish CDMO specializing in microbial-derived biopharmaceuticals, viral vectors, and pDNA. A niche European peer with comparable offerings in GMP manufacturing for gene therapy and vaccine programs.
• Polpharma Biologics: Polish biopharmaceutical CDMO with microbial and mammalian cell-based manufacturing capabilities serving global pharma and biotech. Directly comparable CDMO in scale, geography (Central Europe), and biologics service offering.
• Rentschler Biopharma: German family-owned CDMO specializing in microbial and mammalian biopharmaceutical manufacturing. Directly comparable as a German-headquartered biologics CDMO serving similar pharma and biotech customers.
• Celonic Group: German-based CDMO offering development and GMP manufacturing of biologics using mammalian and microbial systems. A regional peer with comparable scale, technology focus, and customer profile.

Broad incumbents

• Eurofins CDMO: Eurofins' CDMO division offers a broad portfolio of biologics manufacturing services including microbial expression. A broader incumbent with comparable services but operating as part of Eurofins' larger testing and manufacturing conglomerate.
• Lonza Group: World's largest CDMO with comprehensive microbial and mammalian biologics manufacturing capabilities, including pDNA and mRNA services. A broad incumbent with overlapping capabilities but at vastly larger scale and broader modality portfolio.
• Boehringer Ingelheim BioXcellence: Boehringer Ingelheim's biopharmaceutical contract manufacturing business offers microbial and mammalian biologics services globally. A broad incumbent and German-headquartered competitor in biopharmaceutical CDMO services.

Emerging players

• Cytovance Biologics: US-based CDMO offering microbial and mammalian biologics manufacturing including pDNA, proteins, and antibodies. An emerging peer with comparable microbial CDMO services for early- and mid-stage biotech customers.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/richter-helm-biologics

Compliance8 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 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 Richter-Helm