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Biopharmaceutical Development and GMP Manufacturing: Preclinical to Commercial Supply August 2014

Kai Pohlmeyer

August 15, 2014

1 Min Read

BPI_A_141207AR41_O_F0002g.jpgRichter-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_F0001g-150x150.jpgRichter-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-150x150.jpg

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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