October 1, 2012 (Vol. 32, No. 17)

Expanded Service Portfolio to Face Future Challenges in Biopharmaceutical Contract Manufacturing

Outsourcing is one of the major global trends in the biopharmaceutical industry. It takes more and more specific know-how to face the challenges for biopharmaceutical manufacturing, including increasing price and cost pressure, increasing competition from me-too products, the need for high flexibility, and the ever changing 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 robustness at least for certain process steps. During the past years the biomanufacturing industry has made substantial improvements in expression and fermentation technologies. In terms of microbial production, innovative E. coli expression 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 expression 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 technology 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 reported 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 product 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 different customers from small startups to big pharma. The project approach, e.g., regarding the regulatory consultancy required, will be extremely dependent on this. Project management 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 alliances between developers and manufacturers.

Fill & Finish Services

We offer high-end fill and finish manufacturing services for injectables, production services available for R&D, preclinical/toxicological, clinical ,or commercial batches, in our brand new facility in Hungary. Gedeon Richter, our reputable parent company, built a commercial plant in Debrecen designed to perform fill and finish operations:

  • Developing and launching new or improved products, services, and technologies with high added value that meet stringent requirements and permit economization in every aspect.
  • Wide range of batch sizes. We can accommodate 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.
  • Offering filling, freeze-drying, and packaging of biotechnological and special products as well as parenteral products.
  • Available are: 1,100 m² clean room, two filling lines (syringe and vial/cartridge/lyophilisation line), Restricted Access Barrier System (RABS system).

New Location Close to Hamburg Airport

Richter-Helm Biotec and Richter-Helm Biologics decided to pool their strengths and have moved together in a completely refurbished building at Suhrenkamp 59, Hamburg-Fuhlsbüttel, right next to Hamburg Airport. The new location, with a total area of 2,200 m² for laboratories and offices, provides space for up to 90 employees in Process Development, Quality Control and Quality Assurance, Business Development, 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. Welcome to our new site!

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

Previous articleWet-AMD Therapy Approved in Japan
Next articleNovo Nordisk Drops Phase III Hemophilia Drug