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

  • GMP state-of-the-art facilities for microbial production
  • fermentor scale up to 1,500 L
  • strong expertise in Escherichia coli and yeast (e.g., Pichia)
  • preclinical/clinical trials to market supply at a large scale.


 


 

 

Out-licensing

 

Richter-Helm out-licenses its own biosimilar developments in

  • women’s health (osteoporosis)
  • infectious diseases (hepatitis).

 

Active Pharmacetical Ingredients

 

Sales of active pharmaceutical ingredients

  • Teriparatide
  • IFN alpha 2a.

 

Fill–Finish

 

Full fill and finish operation will begin in 2013 and will feature

  • 1,100 m2 cleanroom
  • two filling lines built according to the latest regulatory requirements (syringe and vial/cartridge/lyophilisation line)
  • labeling machines
  • unbuilt cleanroom area 130 m2 for expansion
  • special room for small batches.
About the Author

Author Details
Dr. Kai Pohlmeyer is head of business development, +49-40-2375-2430, k.pohlmeyer@richter-helm-biotec.eu.

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