Biopharmaceutical Development and GMP Manufacturing: Preclinical to Commercial Supply

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Richter-Helm LogoRichter-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

BPI_A_141207AR41_O_F0001gRichter-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 PipelineBPI_A_141207AR41_O_F0003g

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

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