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.

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