Richter BioLogics

Hamburg, Germany

Profile last updated: 2026-10-06

Claimed Profile Plasmid DNA Recombinant Proteins VHH/Nanobodies Bacterial Vaccines Biologics

No confirmed program data — ClinicalTrials.gov verification pending · Last scored 2026-09-07

82.9

Signal Score

○ FDA Inspections ○ Clinical Trials ○ SEC Filings ✓ Press (1) ✓ EMA GMP (9) ○ MHRA GMP

Quick Facts: Richter BioLogics

Signal Score: 82.9/100 (as of 2026-09-07)
Quality Compliance: 100.0/100
Headquarters: Hamburg, Germany
Founded: 1987
Max Bioreactor Scale: 1500 L
Website: https://www.richterbiologics.eu/
Modalities: Plasmid DNA, Recombinant Proteins, VHH/Nanobodies, Bacterial Vaccines, Biologics
Active Programs: Data pending
Data Sources: FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
Scored By: CDMO Signal — independent CDMO intelligence platform

About Richter BioLogics

Pure-play microbial CDMO (est. 1987). 100% owned by Gedeon Richter since Sep 2024. Two cGMP sites in Germany: Hamburg (HQ, PD, analytical), Bovenau (10,000 m², 300L and 2x 1,500L). Specializes in E. coli and P. pastoris expression. Proprietary RB-pART pDNA platform. Approved by EMA, FDA, PMDA, ANVISA, Health Canada, MFDS. Tripled capacity in 2024 via EUR 100M Bovenau expansion. Successful FDA inspection in 2026 with zero observations.

Signal Score & Pillar Breakdown

Scores are being republished. Scores are being republished under methodology v3.3. The score shown is the last complete v3.2 result, which is also what directory listings and search results show. A pillar breakdown is not shown because the current one is computed under v3.3 and would not explain a v3.2 score. Regulatory evidence below is current.

Quality Compliance

FDA InspectionsNo US records on file

EMA GMP Certificates9 on record

Operations —

No ClinicalTrials.gov facility matches confirmed for this manufacturer.

Programs — no verified data

Sponsors— no verified data

ModalitiesPlasmid DNA, Recombinant Proteins, VHH/Nanobodies, Bacterial Vaccines, Biologics

Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.

Financial Stability

Profile-based financial assessment

SEC FilingsPrivate company

Capacity

Profile-based capacity assessment

Recent Press1 articles

Richter BioLogics EMA GMP Compliance 9 certificates

2025-11

2025-02

2022-06

2017-06

Compliant Non-Compliant

Certificate	Site	Country	Inspection Date	Status
DE_NI_02_GMP_2025_0058	Richter BioLogics GmbH	Germany	2025-11-26	COMPLIANT
DE_NI_02_GMP_2025_0057	Richter BioLogics GmbH	Germany	2025-11-26	COMPLIANT
DE_SH_01_GMP_2025_0041	Richter BioLogics GmbH	Germany	2025-02-05	COMPLIANT
DE_SH_01_GMP_2025_0040	Richter BioLogics GmbH	Germany	2025-02-05	COMPLIANT
DE_SH_01_GMP_2022_0044	Richter-Helm BioLogics GmbH & Co. KG	Germany	2022-06-30	COMPLIANT
DE_SH_01_GMP_2024_0044	Richter-Helm BioLogics GmbH & Co. KG	Germany	2022-06-30	COMPLIANT
DE_SH_01_GMP_2024_0043	Richter-Helm BioLogics GmbH & Co. KG	Germany	2022-06-30	COMPLIANT
DE_SH_01_GMP_2022_0043	Richter-Helm BioLogics GmbH & Co. KG	Germany	2022-06-30	COMPLIANT
DE_SH_01_GMP_2017_1032	Richter-Helm BioLogics GmbH & Co. KG	Germany	2017-06-29	COMPLIANT