Richter-Helm, the CDMO matching your needs
Biotechnology production includes a broad range of various approaches to produce pharmaceuticals. Different sources for products can be used, like mammalian cell culture or microbial fermentation processes in bacteria and yeast. While mammalian products are in large part monoclonal antibodies, microbial-derived products, especially, including a broader variety of product classes: therapeutic proteins, some of them modified, e.g. pegylated, peptides, antibody formats e.g single domain antibodies, bacterial vaccines and plasmid DNA as critical raw material or drug substance compete for production capacities. All of these classes need to be produced to the highest international standards of cGMP. From this long list of product classes, it is obvious that related production is as versatile as the products themselves. In conclusion, flexible manufacturing capacities at different manufacturing scales and highly variable production trains are needed. To cope with such needs a CDMO with a broad technical and scientific expertise, flexibility and highest cGMP standards is required. Richter-Helm offers such flexible services to the highest standards. Richter-Helm process and analytical development is located in Hamburg, Germany. Richter-Helm operates two state-of-the-industry manufacturing facilities in Hannover and Bovenau. At Richter-Helm, new projects can be initiated at various stages, e.g. starting with the gene, strain and process development or via technology transfer in all phases of development or commercial phase. Process development is based on a broad range of experience in microbial fermentation and related purification approaches. Additionally, supportive characterisation studies and models for large scale process validation are executed.
Richter-Helm manufacturing facilities provide a broad range of bioreactor scales, covering a fermenter volume from 10L to 1,500L for cGMP production. Specific requirements like methanol feed for fermentation of Pichia pastoris or multiple fermentation runs of various bacteria for vaccination can be offered as CDMO service. In most cases, mid-stream and down-stream operations will follow fermentation.
Richter-Helm further provides state-of-the-art mid- and downstream processing, as well as specialised solutions, such as preparative HPLC or pegylation, catalysed either enzymatically or chemically.
In conclusion, Richter-Helm is able to help customers to meet their individual demands. Richter-Helm is well known for its unique combination of quality, flexibility and experience (Figure). This triangle in combination together with the excellent manufacturing facilities capacity manifests the current market position.
Richter-Helm BioLogics GmbH & Co. KG