Your expert microbial CDMO for biotechnological and biopharmaceutical products
Richter BioLogics is a leading and steadily growing, Germany-based GMP compliant contract manufacturer (CDMO) of biopharmaceuticals specialized in products derived from bacteria and yeasts.
Over the past 35+ years we gained substantial experience in the development and manufacture of different product classes including antibody-like scaffolds, plasmid DNA, proteins, and vaccines. The company currently operates a development facility and two cGMP manufacturing facilities with bioreactor capacities of up to 1,500 litres, enabling GMP manufacturing for phase I to III up to commercial supply. By expanding our production capabilities we will triple our production capacities by adding a total area of about 10,000 sqm and two additional bioreactors with capacities of 300L and 1,500L fermentation volume for microbial production.We further expand our process devellopment department and are prepared to take further and new projects.
With flexibility, high-quality services, commitment to good manufacturing practice and total transparency our experienced teams offer reliable and highly specialized contract development and manufacturing services to support the global pharmaceutical and biotechnological industries.
To meet the high quality requirements, Richter BioLogics consistently works to the highest standards of pharmaceutical quality.
This has been verified by major regulatory bodies including EMA, FDA, ANVISA, PMDA and MFDS as well as by numerous customer audits.
Our Mission
Richter BioLogics is a leading and steadily growing biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with manufacturing facilities in Germany approved by international authorities. We provide high quality services from process and analytical development to GMP-compliant commercial manufacturing.
We are a strong partner with a broad expertise and an extensive track-record to execute projects at various stages. It is our daily goal to meet customer demands through continuous improvement, innovation and expansion of our capacities. We listen to our clients and jointly move projects forward. We deliver reliably, fast and yet with the highest manufacturing excellence. We care for our people and develop talents. In our inspiring work environment our highly skilled and motivated people successfully advance projects in a flexible and transparent manner.
We enable our partners to bring biopharmaceutical products to market in time and improve the lives and health of people.
Our Vision
First in class CDMO delivering services and products to the full satisfaction of our partners and the health of people
- we provide quality
- we focus on our customers
- we have the right people
- we drive success
Facts about Richter BioLogics
From early development through to commercial manufacturing, Richter BioLogics is your partner of choice.
- Founded in 1987 and with more than 35 years of experience in biopharmaceuticals production
- Contract development and manufacturing of biopharmaceuticals in microbial systems (Pichia and E.coli)
- Medium-sized Joint Venture
- Headquarters based in Hamburg
- Two state-of-the-industry manufacturing facilities in Hannover and Bovenau
- Broad range of bioreactor scales covering fermenter volume from 10 L - 1,500 L
- Production area more than 5500 m²
- Constant expansion of capacities as needed
- Complete Drug Substance development & manufacturing from one source
- Outsourcing partner for clients worldwide
- Clients belong to Small, Mid and Big Pharma and Biotech companies
Safety First
Health and Safety Protection
- Health is our greatest good. We ensure that every employee can work in a safe working environment. Together we strive for zero incidents and zero accidents.
- Our employees are the basis of our success. Essential criteria in our thoughts and actions are Health, Safety and well-being of our employees as well as the safety of our customers, visitors and neighbours. That is why we invest in preventive occupational safety, comprehensive health protection and leading healthcare.
Our Duties and Responsibilities
- All employees follow the regulations and instructions applicable in their area of responsibility. According to their knowledge and skills, they bear personal responsibility for their own safety and the safety of others.
- Every Executive actively contributes to the safety of the production plants, prevention of accidents and protection of health. For this we use interactive tools such as regular SAM-based instructions. Occupational Health and Safety is an integral part of the agenda of team meetings. Every Executive is obliged to behave in an exemplary manner and actively demands awareness for Health and Safety issues.
Feedback culture
- In order to continuously develop our safety- and health protection, we make use, for example, of the reporting of near misses and integration of feedback systems. An open communication culture and constructive feedback further connects our employees and our Executives
CONFERENCES
Connect with our qualified team to learn more about Richter BioLogics´s capabilities. Richter BioLogics will be present at the following conferences.
CDMO Business
Date
Location
Event
Contact us to arrange a virtual meeting or a telephone conference.
Job Fairs
Date
Location
Event
Contact us to arrange a virtual meeting or a telephone conference.
Biotech in Germany: The History of Richter Biologics
- Grand opening of new facility at Bovenau site
- GR becomes 100% owner and Richter-Helm becomes Richter BioLogics
Major Expansion of manufacturing capacity at Bovenau site
Collaboration with Inovio Pharmaceuticals Inc. to manufacture Inovio´s INO-4800 DNA vaccine candidate targeted against the novel coronavirus (SARS-CoV-2)
FDA approval
FDA approval
Implementation of P. pastoris technology
Acquisition by Gedeon Richter Plc and HELM AG for establishment of a joint venture CDMO
Initiation of GMP manufacturing in Bovenau
Entering in contract GMP manufacturing business
Foundation of Pharma Biotechnologie Hannover one of the first manufacturers of recombinant proteins in Germany.
Our biotech development and production facilities
Richter BioLogics´s Headquarters is located in Hamburg, Germany. Our two state-of-the-art production facilities are based in Hannover and Bovenau, Germany.
Facilities for mammalian cell based CDMO services – including Fill & Finish for both microbial and mammalian products – are offered by our mother company Gedeon Richter located in Budapest and Debrecen, Hungary. To reach Gedeon Richter please click on the link at the bottom of the map.
Our development and production facilities
Richter BioLogics´s Headquarters is located in Hamburg, Germany. Our two state-of-the-art production facilities are based in Hannover and Bovenau, Germany.
Facilities for mammalian cell based CDMO services – including Fill & Finish for both microbial and mammalian products – are offered by our mother company Gedeon Richter located in Budapest and Debrecen, Hungary. To reach Gedeon Richter please click on the link at the bottom of the map.
focus
- Process Development
- Quality Control & Quality Assurance
- Business Development & Project Management
- Administration
Hamburg
Richter BioLogics´s Headquarters & Development Center is located in Hamburg, Germany.
In our Process Development and Quality Control units, we develop and optimize clients processes and have established and qualified analytical methods necessary for the characterization of process intermediates, drug substance and drug product.
focus
- Process Development
- Quality Control & Quality Assurance
- Business Development & Project Management
- Administration
focus
- GMP compliant multipurpose facility
- Manufacturing site with up to 300 L
- Microbial production
- Clinical and commercial supply
Hannover
Richter BioLogics´s GMP compliant multipurpose Manufacturing Site with 1000m² production area and fermenter volumes of up to 300 L is located in Hannover, Germany.
focus
- GMP compliant multipurpose facility
- Manufacturing Site with up to 300 L
- Microbial production
- Clinical and commercial supply
focus
- GMP compliant multipurpose facility
- Manufacturing site with up to 1,500 L
- Microbial production
- Clinical and commercial supply
Bovenau
Richter BioLogics´s GMP compliant multipurpose Manufacturing Site with 4500 m² production area and fermenter volumes of up to 1,500 L is located in Bovenau, Germany.
focus
- GMP compliant multipurpose facility
- Manufacturing Site with up to 1500 L
- Microbial production
- Clinical and commercial supply
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Stay ahead of the curve. Visit our News section for the latest updates and insights directly related to our company’s advancements.
Our two multiproduct GMP facilities are run by highly motivated and experienced teams. A proven technology transfer approach lets us smoothly adopt and implement processes from our clients or our own process development department.
Pick your method from our large portfolio. All methods can be applied for development or GMP-compliant testing, depending on your needs.
