Richter-Helm triples capacity at Bovenau site
Richter-Helm, a leading steadily growing Germany-based contract development and manufacturing organization (CDMO), offers excellent services in the continuously growing market of pharmaceutical biotechnology. Two additional bioreactors with capacities of 300 litres and 1,500 litres for microbial production will be added. This includes also the establishment of mid- and downstream processing and supporting utilities on a total area of about 10,000 m².
A broad range of various approaches exists to produce biopharmaceuticals. Different manufacturing strategies can be used, like mammalian cell culture or microbial fermentation of bacteria or yeast. Microbial derived products can be distinguished into product classes: therapeutic proteins, peptides, antibody formats, bacterial vaccines and plasmid DNA for use as starting material or drug substance. All of these classes need to be produced to the highest international standards of cGMP and compete for production in highly complex, multipurpose facilities with limited capacities worldwide.
From the long list of product classes, it is obvious that related production is as versatile as the products themselves. Nevertheless, manufacturing can be executed in general with the same equipment. This needs adequate flexibility not only for the equipment itself but also the organizational procedure and the quality system.
After completion of conceptual and basic design studies, Richter-Helm yet started the construction of two highly flexible production trains with fully separated flows in a new facility building. The two new bioreactors will be installed with capacities of 300 and 1,500 litres. Those can be operated in parallel for different products. The midstream- and downstream operations will be executed in suites in the same building. Individual bioreactors and suites can be arranged variably to offer multiple combinations for any manufacturing process. This allows a flexible combination of processes demanding different volumes for up- and downstream capacities.
Construction work on the building complex began in May. Detailed Engineering is in strong progress. It is expected that the ambitious construction of the new facility will be completed within the next two years. By the end of 2023, full-scale operations and manufacturing shall begin.
After expansion is completed, Richter-Helms manufacturing facilities will provide triplicate capacities within the current range of bioreactor scales, covering fermenter volumes from 10 to 1,500 litres for cGMP production. Specific requirements like 100% oxygen aeration for high cell density fermentation and methanol feed for the cultivation of Pichia pastoris are offered as CDMO services for all production trains in Bovenau. Richter-Helm further provides state-of-the-art, highly flexible downstream processing.
Richter-Helm takes the next steps as a CDMO to combine reliable market supply for registered products and sufficient capacities to further support with material for new clients, new clinical studies and development of new products.
Learn more: www.richter-helm.eu and follow us on LinkedIn.
Contact
Dr Thilo Kamphausen
Director of Business Development
t.kamphausen@richter-helm-biologics.eu
Dr Kai Pohlmeyer
Managing Director
k.pohlmeyer@richter-helm-biologics.eu
SLAS
SLAS - Alexandra Csuport Photography