Biopharmaceutical Development and GMP Manufacturing

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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; k.pohlmeyer@richter-helm-biotec.eu.

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