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., attenuated whole cell vaccines).
Richter-Helm offers customized solutions for all steps in biopharmaceutical projects through contract development and manufacturing services featuring
-
Development of production strains (Escherichia coli, Pichia)
-
Establishment of MCB/WCB
-
Development of fermentation (1 to 1,500 L) and downstream processes
-
Development of analytical methods, including bioassay development
-
Validation of analytical methods
-
GMP manufacturing for clinical phase I to III
-
Commercial GMP manufacturing
-
Process validation
-
In-house quality control (QC) testing and release; stability studies according to ICH.
Richter-Helm out-licenses its own biosimilar developments in
-
women’s health (osteoporosis)
-
infectious diseases (hepatitis).
Sales of active pharmaceutical ingredients
-
Teriparatide
-
IFN alpha 2a.
We offer high-end fill and finish manufacturing services for injectables, production services for clinical and commercial batches.
Author Details
Dr. Kai Pohlmeyer is head of business development, + 49-40-55 290-430;