- recombinant proteins (e.g. cytokines, growth factors, antibody fragments, surface antigens)
- plasmid DNA
- microbial vaccines (e.g., live and attenuated whole cell vaccines), according to the EU and US GMP guidelines (FDA approval 2013).
- Development of production strains (Escherichia coli, Pichia pastoris)
- Establishment of MCB/WCB
- Development of upstream (fermentation volume from 1 to 1,500 L) and downstream processes
- Development of analytical methods, including bioassay development
- Validation of analytical methods
- GMP manufacturing for clinical trials phase 1–3
- Commercial GMP manufacturing
- Process validation
- In-house quality control (QC) testing and release, stability studies according to ICH
In addition, Richter-Helm is the platform of Gedeon-Richter and Helm AG for worldwide licensing options as well as partnerships for the codevelopment and marketing of biopharmaceutical development projects. Currently Richter- Helm’s own pipeline consists of two biopharmaceutical development projects (infectious diseases, orthopedics) which are ready for partnering.
Dr. Kai Pohlmeyer is head of business development, 49-40-55 290- 430; email@example.com.