August 15, 2014
Richter-Helm has more than 25 years of experience in the development and good manufacturing practice (GMP)–compliant production of a wide range of biopharmaceuticals, including
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).
Customized Solutions
Richter-Helm offers customized solutions for all steps in biopharmaceutical projects through contract development and manufacturing services, including
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
Development Pipeline
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 protected].
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