DEVELOPMENT AND MANUFACTURE OF MICROBIAL-DERIVED BIOPHARMACEUTICALS
Richter BioLogics is a leading and steadily growing biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with three cGMP-compliant manufacturing facilities in Germany.
We specialize in products derived from bacteria and yeasts. Over the past 35+ years we gained substantial experience in the development and manufacture of product types that include recombinant proteins and peptides, antibody-like scaffolds (VHH/ Nanobodies, Fab fragments), plasmid DNA, and bacterial vaccines.
We move our clients projects forward: flexible, transparent, fast
Our Expertise
- Strong track record in microbial production of biopharmaceuticals
- Specialized in products derived from bacteria and yeasts
- Customer base includes established large pharmaceutical companies, small- and mid size pharma and biotech companies worldwide
- Production of commercial and both early- and late-stage products
- Project Management
- Strain-/ Process- and Analytical Development
- Bioassay development
Our Microbial Capabilities
- Headquarters in Hamburg and three GMP-compliant manufacturing facilities in Hannover and Bovenau, Germany
- GMP facilities approved by major regulatory bodies including EMA, FDA, PMDA, ANVISA, and MFDS
- Flexible production capabilities with fermenter volumes from 10L to 1500L and suitable DSP capacities
- Batch and fed-batch manufacture
- Methanol feeding for Pichia expression
- Continuous expansion of process development and quality control capacities at all sites
- Expansion of production capacities
Our company in numbers
Frequently Asked Questions
What is a CDMO?
A Contract Development and Manufacturing Organization (CDMO) specializes in providing outsourced services to pharmaceutical and biotech companies for drug development and manufacturing. CDMOs offer essential support throughout the drug lifecycle, from development to scalable manufacturing.
Why choose Richter BioLogics as your CDMO?
Richter BioLogics offers over 35 years of expertise in delivering high-quality CDMO services. Our customer-centric approach ensures seamless project management, supported by experienced teams who understand the challenges of the pharmaceutical industry. We manage projects end-to-end, from gene and cell line development to product release, minimizing risks, saving time, and reducing costs through fewer technology transfers.
What does end-to-end service mean at Richter BioLogics?
Our end-to-end service is tailored to meet the customer’s specific needs. It includes:
- Complete Development: From strain development to custom production and product release.
- Technology Transfers: Efficiently transitioning existing processes to large-scale manufacturing.
- Clinical Trial Support & Market Supply: Producing materials for clinical trials and full-scale commercial manufacturing.
What areas of development does Richter BioLogics specialize in?
Richter BioLogics specializes in process development, analytical development, and GMP-compliant commercial manufacturing for biologics. We ensure precision and efficiency at every stage to meet stringent industry standards and client expectations.
Where can I learn more about Richter BioLogics CDMO services?
To explore our capabilities in detail or to discuss your project requirements, visit our site in detail or contact our customer team directly. We’re here to guide you through every step of the process.
A Contract Development and Manufacturing Organization (CDMO) provides outsourced development and manufacturing services for drug products to pharmaceutical and biotech companies. CDMOs support organizations by streamlining processes from drug development to manufacturing.
What production systems does Richter BioLogics use?
Richter BioLogics specializes in E. coli, P. pastoris, and cell-free systems, and supports additional microbial strains upon request.
What types of biologics does Richter BioLogics produce?
Our core competencies include manufacturing a wide range of biologics, such as:
- Nanobody/VHH
- Therapeutic proteins and peptides
- Bacterial Vaccines
- Plasmid DNA (pDNA)
We also produce proteins in a Cell-free protein synthesis system.
What analytical services does Richter BioLogics provide?
Most analytical testing is conducted in-house across our Headquarters and manufacturing sites, ensuring consistency and precision. We perform full services to release bulk API, bulk product as well as sepcific DP tests where we provide development & validation of methods.
At our GMP labs in Hamburg, we offer specialized analytical tests, including cell-based assays and potency assays. Additionally, we can manage external analytics for specialized requirements.
Where is Richter BioLogics located?
Richter BioLogics operates one development and three production facilities:
- Hamburg, Germany (Headquarters): Home to GMP analytical labs, analytical development labs, and microbial Process Development (PD).
- Hannover, Lower Saxony, Germany
- Bovenau, Schleswig Holstein, Germany (Two cGMP manufacturing facilities for microbial production).
What production scales does Richter BioLogics support?
Richter BioLogics offers fermentation capacities from 10L to 1,500L, supported by cutting-edge equipment. Our production sites offer capacities of:
- 2x300L fermenters
- 2×1,500L fermenters
- 100% oxygen aeration technology for high-yield fermentation
- MeOH feed
What quality grades are available at Richter BioLogics?
We produce materials a variety of quality grades, including:
- Non-GMP
- High-Quality
- Critical Raw Material (CRM)
- GMP-compliant
Does Richter BioLogics have its own pipeline of assets?
No, Richter BioLogics is a 100% CDMO dedicated to microbial-based biopharmaceutical production. We do not maintain our own pipeline of assets.
What is Richter BioLogics’ regulatory history?
Richter BioLogics is accredited by major global regulatory authorities, including EMA, FDA, PMDA, Anvisa, Health Canada, Ministry of Health and Welfare Taiwan, MFDS Korea, and others. All GMP production sites are governed by a unified GMP system to ensure compliance.
Can Richter BioLogics assist with regulatory submissions?
Yes, Richter BioLogics supports clients with regulatory compliance and submission assistance through its extensive experience and adherence to global standards.
How are customer projects managed at Richter BioLogics?
Richter BioLogics manages projects with a robust and customer-centric approach, including:
- Dedicated Project Managers
- Person-in-plant (PiP) – philosophy
- Opportunities for Customer Audits
- Steering Committees for progress reviews
How can I get in touch with Richter BioLogics to discuss my project needs?
We’re happy to assist you with your project requirements. Please contact us through our website or via email at BusinessDevelopment@richterbiologics.com.
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