Flexible. Reliable. Focussed.

Different approaches exist to produce biopharmaceutical products, which means different manufacturing strategies can be used, like mammalian cell culture or microbial fermentation of bacteria or yeast.

Microbial manufacturing
Microbial-derived products, made by Richter-Helm, include a variety of product classes including therapeutic proteins and peptides, antibody formats (e.g., VHH), bacterial vaccines, and plasmid DNA (pDNA). pDNA can either be used as drug substance  or as specific starting material for mRNA production, virus production or as matrix in cell-free expression systems. Regardless of the type of use all product classes and qualities compete for production in highly complex, multipurpose facilities whose capacities are limited worldwide.

Highly flexible
From the long list of product classes, it is obvious that related production is as versatile as the products themselves. Detailed knowledge of molecules and experience in the production of such is mandatory for each of the classes.  Nevertheless, from the technical aspect, manufacturing can be executed in general with the same equipment. A prerequisite for high-class manufacture within short timelines is adequate flexibility of the equipment in line with organizational procedures and the quality system.

Along with the constant growth of Richter-Helm´s business and the expansion of production capacities, both the equipment and the technologies in the areas of development, manufacturing and analytics are constantly being newly established and further developed.

Capacity expansion
Recently, Richter-Helm announced the next important milestone and started the facility expansion of its Bovenau site. By the end of 2023, the expansion will be completed. Richter-Helm´s manufacturing facilities will then provide triplicate capacities within the current range of bioreactor scales, covering fermenter volumes from 10L to 1,500L for cGMP production.

State-of-the-art services
Specific requirements like 100% oxygen aeration technology for high cell density fermentation of Escherichia coli or yeast and methanol feed technology for cultivation of Pichia pastoris as well as highly flexible downstream processing are offered as state-of-the-art CDMO services for all production trains in Bovenau.

Keeping focussed
As a microbial CDMO, Richter-Helm ensures reliable market supply for registered products, including campaign productions with multiple fermentation runs, and sufficient capacities to also further support also new clients with material for clinical studies and development of new products.

Learn more about Richter-Helm´s capabilities and capacities: www.richter-helm.eu and follow us on LinkedIn.

Contact
Dr Thilo Kamphausen
Director of Business Development
T +49 (4331) 1230 – 451
t.kamphausen@richter-helm-biologics.eu

Dr Kai Pohlmeyer
Managing Director
T +49 (40) 55290 – 430
k.pohlmeyer@richter-helm-biologics.eu