July 23, 2021 PAO-07-21-CL-08
Continuous growth of the biotechnology market and the increasing need for flexible manufacturing solutions for pharmaceutical production is a known trend. Since the COVID-19 pandemic, the CDMO business segment is anticipated to grow even more. Richter-Helm is a successful and growing contract manufacturer with more than 30 years of experience. Now, Richter-Helm is taking the next step in reacting to the global demand for CDMOs, adding a new manufacturing facility to its Bovenau, Germany, location. The expansion will triple biopharmaceutical production capacity and 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 and peptides, antibody formats, bacterial vaccines, and plasmid DNA (pDNA). pDNA production in particular is moving more and more into focus, where the pDNA serves as starting material for, for example, mRNA, viral vectors, 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 in the past year.
Richter-Helm started construction of two highly flexible production trains with fully separated flows in a new facility building this May. Two new bioreactors with capacities of 300 and 1,500 liters will be installed. The facilities will provide three-fold cGMP production capacities within the current range of bioreactor scales, covering fermenter volumes from 10 to 1,500 liters. 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 upstream and downstream capacities. Equipment can be adapted to specific needs easily. It is expected that construction of the new facility will be completed within the next two years. By the end of 2023, the first production runs will be executed.
100% oxygen aeration technology for high-cell-density fermentation of E. coli or yeast will in the end lead to higher product yield for proteins or pDNA. Methanol feed technology for cultivation of Pichia pastoris or campaign productions with multiple fermentation runs and downstream processes of a specific product 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), as well as established analytical platforms for pDNA products, including a generic and validated QC testing approach with a comprehensive set of methods, complete the CDMO´s capabilities.
Richter-Helm will be prepared for the future, grows with the challenges, and fully supports its customers to meet their individual demands.
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.
Dr. Thilo Kamphausen, Director of Business Development / T +49 (4331) 1230 – 451 / email@example.com
Dr. Kai Pohlmeyer, Managing Director / T +49 (40) 55290 – 430 / firstname.lastname@example.org
Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research - Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.
Richter-Helm BioLogics is a leading, Germany-based GMP compliant contract manufacturer of biopharmaceuticals specialized in products derived from bacteria and yeasts.
Over the past 30 years we gained substantial experience in the development and manufacture of different product classes e.g. recombinant proteins, antibodies, plasmid DNA and vaccines. The company currently operates a development facility and two cGMP manufacturing facilities with bioreactor capacities of up to 1,500 liters, enabling GMP manufacturing for phase I to III up to commercial supply. Richter-Helm works to the highest standards of pharmaceutical quality which has been verified by major regulatory bodies including EMA, FDA, ANVISA, PMDA and MFDS.