German biotechnology company Richter-Helm BioLogics has completed the modernisation of its GMP production facility in Hanover.
The company is now able to offer GMP-production capacity in a 300L fermentation volume and corresponding capacity for the production of recombinant proteins, plasmid DNA and vaccines deriving from microbial fermentation at the site.
Richter-Helm has been producing these products at the site for more than 20 years. It now has cleanrooms of class D up to class A in B at Hanover, which where designed and built strictly following a GMP room concept. Planned for production of biopharmaceutical test samples for all clinical phases, the facility is also suitable for market supply. Two bacterial vaccines, which are approved and available, are already produced at this site.
The company says the new facility closes the gap between its research facility and large-scale production in Bovenau, near Kiel.
Richter-Helm now has all common fermentation scales up to 1500L available for GMP production at Hamburg, Hanover and Bovenau.