Richter-Helm GmbH & Co. KG
Richter-Helm is a German-based contract development and manufacturing organization (CDMO) that specializes in process development and GMP-compliant manufacture of products derived from microbial expression systems, principally bacteria and yeasts.
Richter-Helm is one of Europe’s longest established biotechnology companies, with more than 25 years of experience in the development and GMP production of recombinant proteins, plasmid DNA and microbial vaccines.
Richter-Helm offers services with highest pharmaceutical quality, confirmed by many audits of customers and regulatory authorities (FDA, EMA, ANVISA, MFDS). The services include process development and GMP manufacturing for clinical trials as well as commercial supply.
In addition, the company is looking for strategic partnerships based on co-development and risk sharing models for biopharmaceutical products that are of interest for Richter-Helm’s mother companies Gedeon Richter and Helm AG.
Products and Services
With an experienced team of more than 150 employees, Richter-Helm offers customized solutions for all steps in biopharmaceutical projects via contract development and manufacturing services in its approved cGMP facilities.
Richter-Helm is a microbial manufacturer of products derived from bacteria and yeasts that include:
- Recombinant proteins (e.g. cytokines, peptides, antibody fragments, growth factors)
- Plasmid DNA
- Bacterial vaccines (e.g. attenuated whole cell vaccines)
Richter-Helm offers a suite of development and manufacturing services tailored to the needs of pharmaceutical and biotech companies with microbial-derived products in their pipeline. These services include:
- Strain development
- Establishment and characterization of cell banks (MCB/WCB)
- Process development and optimization
- Development and validation of analytical methods for IPC as well as release testing (incl. bioassays)
- Stability studies (preliminary and ICH-conformal)
- Establishment of reference standards
- Technology transfer of processes and analytical methods
- GMP-compliant manufacturing for clinical trials
- Process validation
- Commercial manufacturing
Richter-Helm has successfully performed projects for a range of microbial-derived biopharmaceuticals. The company’s extensive experience in manufacturing of bacterial products includes recombinant proteins, bacterial vaccines and plasmid DNA.
In addition, Richter-Helm has produced further ranges of recombinant proteins in yeasts, including enzymes and new antibody formats.
The company has developed its own products in the therapeutic areas of diabetes and osteoporosis, including a highly promising drug now in late-stage clinical trials, which is licensed to partners worldwide.
History and Structure
The company was established in 1987 and began contract GMP manufacturing in 1989. In 1998, it completed a new development center in Hamburg and in 2003 opened a further GMP production site at nearby Bovenau, Germany.
Richter-Helm was formed in 2007 as a joint venture between Gedeon Richter, the largest Hungarian pharmaceutical company, and Helm AG, one of the world’s leading independent chemical marketing enterprises. From 2008, Richter-Helm started own development projects from which one is currently in late-stage clinical trials.
The US Food and Drug Administration (FDA) awarded Richter-Helm full approval for GMP production in 2013, covering the sites in Hamburg and Bovenau. In 2014 the company further expanded capacity at the Bovenau site.
Richter-Helm’s 2,200 m² development center in Hamburg houses GMP-compliant QC labs as well as process development labs and undertakes strain development, process development and establishment of analytical methods.
This is supplemented by two dedicated GMP manufacturing sites. The production plant in Hannover can handle up to 300 L fermentation volume, while the multipurpose manufacturing facility in Bovenau offers up to 1500 L fermentation volume with dedicated downstream processing capacities.
Standards and Compliance
The high pharmaceutical quality standards of Richter-Helm products and services have been confirmed by repeated audits by customers and regulatory authorities.
Richter-Helm has been inspected and approved by leading regulatory authorities, including the US FDA, European Medicines Agency (EMA), Brazil’s ANVISA and South Korea’s Ministry of Food and Drug Safety (MFDS).
Richter-Helm ensures continuous improvement and maintenance of quality through:
- Constant improvements of internal procedures
- Permanent training of personal according to GMP guidelines
- Systematic implementation of advices given by regulatory authorities and customers during audits
- Ongoing efficiency programs
All three sites are GMP certified, while both production facilities have manufacturing licenses for proteins, vaccines and plasmid DNA.
To learn more about Richter-Helm products and services and how they can assist your business, please contact the supplier directly.
- CRO, CMO, CRAMS & CDMO
- Clinical Trials & Studies
- Drug Discovery
- Manufacturing & Production
- Pre-Clinical Research