Biopharmaceutical Development and GMP Manufacturing August 2012
August 1, 2012
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, [email protected].
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