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Biopharmaceutical Development and GMP Manufacturing
Kai Pohlmeyer
August 1, 2013
1 Min Read
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).
Customized Solutions
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.
Out-Licensing
Richter-Helm out-licenses its own biosimilar developments in
women’s health (osteoporosis)
infectious diseases (hepatitis).
Active Pharmaceutical Ingredients
Sales of active pharmaceutical ingredients
Teriparatide
IFN alpha 2a.
Fill–Finish
We offer high-end fill and finish manufacturing services for injectables, production services for clinical and commercial batches.
About the Author
Author Details
Dr. Kai Pohlmeyer is head of business development, + 49-40-55 290-430; [email protected].
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