Richter-Helm is a successful contract manufacturer (CDMO) with more than 30 years of experience and constant growth. Now Richter-Helm takes the next step and follows an ambitious plan to triple manufacturing capacity at its Bovenau site. Continuous growth of biotechnology market and the increasing need for flexible manufacturing solutions for pharmaceutical production is a known trend. Since the Covid-19 pandemic, this became even more evident. It is expected that this trend will continue. The expansion will strengthen Richter-Helm´s position to fulfill customers’ expectations even more.
A broad range of various approaches exist to produce biopharmaceuticals. Different sources for products can be used, like mammalian cell culture or microbial fermentation processes in bacteria and yeast. Microbial derived products include a variety of product classes: therapeutic proteins, peptides, antibody formats, bacterial vaccines and plasmid DNA 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 facilities with limited capacities worldwide. This limitation is due to a growing market and was made even more obvious during the worldwide pandemic since 2020.
From the long list of product classes it is obvious that related high quality production is as versatile as the products themselves. Nevertheless manufacturing can be executed in general with the same equipment in multipurpose facilities. This needs adequate flexibility not only for the equipment itself, but also the organizational procedure and the quality system.
Richter-Helm ensures highest pharmaceutical quality standards as verified by major regulatory bodies including EMA, FDA, PMDA, ANVISA, Health Canada and MFDS as well as by numerous customer audits.
After completion of conceptual and basic design studies Richter-Helm yet started construction of two highly flexible production trains with fully separated flows in a new facility building. Two new bioreactors with capacities of 300 and 1,500 liters will be installed. 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 for flexible combination of processes demanding different volumes for up- and downstream capacities. Equipment can be adapted to specific needs easily.
A few weeks ago construction works started. Detailed engineering is on strong progress. It is expected that ambitious construction of the new facility will be completed within the next 2 years. By the end of 2023 first productions shall be executed.
After completion of the expansion Richter-Helm manufacturing facilities will provide three-fold cGMP production capacities within the current range of bioreactor scales, covering fermenter volumes from 10 to 1,500 liters. Specific requirements like 100% oxygen aeration for high cell density fermentation, methanol feed for cultivation of Pichia pastoris or multiple fermentation runs of various bacteria for vaccination can be offered as CDMO service for all production trains in Bovenau. Richter-Helm further provides state-of-the-art, highly flexible downstream processing. Specialized solutions, such as preparative HPLC or pegylation (catalyzed either enzymatically or chemically) complete the CDMO´s capabilities.
In conclusion Richter-Helm will be prepared for the future and will still be able to help customers to meet their individual demands. Richter-Helm is well known for its unique sense of Quality, Flexibility and Experience.
Richter-Helm consequently takes the next steps as a CDMO. Here reliable market supply for registered products and sufficient capacities for new projects are combined. New projects can start at Richter-Helm with full development or as technology transfer of an existing process for further support with material for new clients, new clinical studies and development of new products.
Learn more: www.richter-helm.eu
Dr. Thilo Kamphausen, Director of Business Development / T +49 (4331) 1230 – 451 / [email protected]