Modernisation of Richter-Helm BioLogics’ Small-Scale GMP-Production Facility in Hannover completed
Richter-Helm BioLogics GmbH & Co. KG completed the modernisation of it´s GMP-production facility in Hannover in September 2009. Hence GMP-production capacity in a scale of 300L fermentation volume and corresponding down-stream capacity for the production of recombinant proteins, plasmid DNA and vaccines deriving from microbial fermentation is now available at the Hannover location.
After successfully modernising the clean room area for purification in 2008, the up-stream processing area, i.e. the area for fermentation and primary recovery of microbial cultures, of this facility is now state of the art. The construction work was completed in September and the new facility is presently undergoing qualification operations. After repeatedly improving its facility Richter-Helm has now clean rooms of class D up to class A in B available at the Hannover location, which where designed and constructed 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 at the market are already produced at this site.
The new facility now closes the gap between Richter-Helm’s research facility and the large scale production in Bovenau near Kiel. Richter-Helm has now all common fermentation scales up to 1500L available for GMP production at three different locations, to serve the customers’ needs for consistent quality from pre-clinical development up to market approval and beyond.
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