RB
Richter-Helm BioTec GmbH & Co. KG (Richter BioLogics)
CDMO · Hamburg, Germany
GMP
Overview
Richter-Helm BioTec, renamed Richter BioLogics after Gedeon Richter became sole owner, is a Hamburg CDMO founded in 1987 with GMP plants in Bovenau. It makes recombinant proteins, peptides, plasmid DNA and antibodies in bacterial and yeast systems. The company reports FDA inspections in 2013, 2018 and 2026, the last with no observations, and holds an active US Type II DMF for teriparatide.
Capabilities
- Microbial fermentation
- Recombinant peptides and proteins
- Process development
- GMP analytics
- Plasmid DNA
Quality signals
| GMP evidence | Yes |
|---|---|
| Certificates of analysis | Not found |
| Third-party testing | Not found |
| ISO certification | Not found |
| Makes own product | Yes, in-house production |