Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D; community with critical information on the tools, technologies, and trends that drive the biotech industry.
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ADVERTORIAL Corporate Capabilities Richter-Helm BioTec Expanded Service Portfolio to Face Future Challenges in Biopharmaceutical Contract Manufacturing that ensures close collaboration and communication between all parties is becoming more and more important, also driven by the trend toward long-lasting partnerships and strategic alli- ances between developers and manufacturers. Fill & Finish Services We offer high-end fill and finish manufacturing services for injectables, production ser- vices available for R&D;, pre- clinical/toxicological, clinical ,or commercial batches, in our brand new facility in Hungary. Gedeon Richter, our reputable parent company, built a com- mercial plant in Debrecen de- signed to perform fill and finish O Richter-Helm BioTec Suhrenkamp 59 22335 Hamburg Germany Phone +49.40.55290.801 Website www.richter-helm-biotec.eu Date Founded 1987 Number of Employees 140 utsourcing is one of the major glob- al trends in the biopharmaceutical industry. It takes more and more specific know-how to face the chal- lenges for biopharmaceutical manufacturing, including increasing price and cost pressure, increasing competition from me-too products, the need for high flexibility, and the ever chang- ing regulatory requirements for manufacturing of biologicals. Implementation of New Process Technologies and Professional Project Management At Richter-Helm the investment in new technology is not focusing only on adding new manufacturing scales: A good alternative is the implementation of new process technologies that can achieve higher yields, and, at the same time, increased quality or better process robust- ness at least for certain process steps. During the past years the biomanufacturing industry has made substantial improvements in expres- sion and fermentation technologies. In terms of microbial production, innovative E. coli ex- pression systems combined with high-density fermentation regimes can lead to yields up to 20 g of the target protein per liter fermentation broth, as was recently shown by Richter-Helm for a fusion protein process. In addition to high product yields, in many cases it is important to find the appropriate ex- pression system for high-quality products that show no or only low expression rates in E. coli. In these cases the use of the Pichia pastoris tech- nology is an additional option. New expression systems lead to high primary product yields, which need to be dealt with in purification processes. Thus, optimization of the downstream processes is necessary. It was re- ported recently that the implementation of EBA technology can reduce the total process cost by up to 56%. Other new purification technologies that can be implemented include multicolumn counter current solvent gradient purification (MCSGP), which reduces the loss of product in chromatography steps. An ongoing trend in biopharmaceutical prod- uct development is the covalent modification of proteins by chemical or enzymatic cross linking (e.g., PEGylation, HESylation, Polyasialation) to increase the half life of the products in humans. All these technologies need to be usable in a real multipurpose facility as well. The technical capabilities of a CMO alone will not be sufficient to serve the future needs of the customers; professional project execution is also a major success factor. It is extremely important for a CMO to be prepared for the different requirements of dif- ferent customers from small startups to big pharma. The project approach, e.g., regarding the regulatory consultancy required, will be ex- tremely dependent on this. Project management Genetic Engineering & Biotechnology News operations: UÊ Developing and launching new or improved products, ser- vices, and technologies with high added value that meet stringent require- ments and permit economization in every aspect. UÊ Wide range of batch sizes. We can accom- modate batches ranging from laboratory (1 liter) to commercial (up to 300 liter) scale production while supporting the entire procedure with our process optimization know-how. UÊ Offering filling, freeze-drying, and packag- ing of biotechnological and special products as well as parenteral products. UÊ Available are: 1,100 m² clean room, two filling lines (syringe and vial/cartridge/ lyophilisation line), Restricted Access Bar- rier System (RABS system). New Location Close to Hamburg Airport Richter-Helm Biotec and Richter-Helm Bio- logics decided to pool their strengths and have moved together in a completely refurbished building at Suhrenkamp 59, Hamburg-Fuhls- büttel, right next to Hamburg Airport. The new location, with a total area of 2,200 m² for lab- oratories and offices, provides space for up to 90 employees in Process Development, Quality Control and Quality Assurance, Business Devel- opment, and Administration. The relocation to the new site strengthens Richter-Helm's global growth strategy for the contract manufacturing and development of in-house products. Wel- come to our new site! Q | genengnews.com | October 1, 2012 | 77