Thursday, 14. May 2009

Bayer Technology Services and Sartorius conclude joint marketing agreement for bioreactors

• Partnerships with Bayer Technology Services and ExcellGene
• Prototypes of new single-use bioreactors at the ACHEMA 2009

Today, Sartorius Stedim Biotech (SSB), a leading international supplier for the pharma and biotech industries, announced a substantial expansion of its technology portfolio in the area of single-use bioreactors. At the 2009 ACHEMA, the world's largest trade show for the process industry, the company is presenting two prototypes of innovative single-use bioreactors that operate based on novel mixing technologies. These cell culture systems were developed in cooperation with the German company Bayer Technology Services GmbH (BTS) and the Swiss cell culture specialist ExcellGene SA . The new bioreactors have been specially designed for the manufacture of monoclonal antibodies, recombinant proteins and vaccines.

So far, Sartorius Stedim Biotech has been offering its customers in the pharma and biotech industries two types of single-use bioreactor: the BIOSTAT CultiBag STR product line, which features a stirred tank design as in conventional reusable bioreactors, and the BIOSTAT CultiBag RM that uses rocking motion for mixing of cell cultures. At the outset of 2010, the company plans to extend its technology portfolio by two further systems: a rotationally oscillating bioreactor and an orbital shake bioreactor. Each of these four agitation technologies offers users specific advantages contingent upon the cells to be produced, the scale-up level of the cell cultures and additional process parameters.

"Based on this comprehensive technology platform, we are taking a huge step forward towards achieving our goal of becoming the global market leader in single-use bioreactors," commented Dr. Oscar-Werner Reif, who is responsible for research and development on Sartorius Stedim Biotech's Board of Directors, on both partnerships. "Whatever our customers' application, we offer the best solution, both technically and economically."

Both partners of Sartorius Stedim Biotech are each bringing new processoptimized cell cultivation technologies, application-enhanced drive and container technology and biological evaluation of the new bioreactors into these cooperative alliances. Sartorius Stedim Biotech provides its expertise in disposable cultivation vessels and bags as well as single-use sensor technology and supplies the bioreactor control system, BIOSTAT, for controlling the new bioreactors. Today, BIOSTAT is already the global benchmark in the market for conventional, reusable bioreactors.

Partnership with Bayer Technology Services GmbH
The purpose of the cooperative alliance between Sartorius Stedim Biotech and Bayer Technology Services (BTS) is to jointly develop the oscillating bioreactor designed by BTS into a market-ready product. In the process, Bayer Schering Pharma AG will be conducting the biological assessments of the bioreactors. The key points for manufacture and marketing have been agreed upon. Both partners intend to have Sartorius Stedim Biotech exclusively manufacture and market this product worldwide. Oscillating bioreactors implement an innovative hydrodynamic movement concept for surface or membrane gassing. In this way, they achieve easily scalable oxygen supply and mixing of cell culture solutions without entrainment of bubbles; i.e., they ensure especially low-shear agitation. The oscillating design eliminates the need for installing stirring devices inside the cultivation vessel. This technology platform currently covers very simple and inexpensive bioreactors for surface gassing. In a later development phase, this oscillating technology is to be extended on up to usage in sophisticated systems with membranes to meet exceptionally high cultivation requirements in terms of shear stress, cell density and scale. Oscillating bioreactors are thus suitable for a broad range of cell culture applications. Sartorius Stedim Biotech plans to initially offer process-scale bioreactors with a working volume of 50 to 200 liters, then with up to 3,000 liters in further scaled-up versions.

Partnership with ExcellGene SA
Under the agreement signed with ExcellGene, Sartorius Stedim Biotech will work together with this company to further develop the orbital shake bioreactor technology developed by ExcellGene in cooperation with Adolf Kühner AG (Birsfelden, Switzerland) in order to make this technology available for process-scale applications with working volumes of up to 2,000 liters. Already at this stage, the prototype of a 250-liter orbital shake bioreactor permitting working volumes of 50 to 250 liters is currently on display at the 2009 ACHEMA trade show. Lab-scale orbital shaking, referred to as "OrbShake," is already a proven method. Predominantly used for screening of media and cultivation conditions and process optimization, the Sartorius Stedim Biotech CultiFlask disposable bioreactor series operates according to this principle. The agitation system of the new process-scale orbital shake bioreactor is likewise based on orbital movement of the disposable cultivation bag, which is installed on an incubation shaker specially designed for this application. This permits cell cultures to be mixed with low shear stress. The absence of a stirring device inside the cultivation bag transforms this bioreactor into an especially cost-effective solution. The bioreactor is fully scalable from milliliter to cubic meter volumes. The company plans to use shakers made by the Swiss company Adolf Kühner AG in these bioreactors.

A Profile of Sartorius Stedim Biotech
Sartorius Stedim Biotech is a leading provider of cutting-edge equipment and services for the development, quality assurance and production processes of the biopharmaceutical industry. Its integrated solutions covering fermentation, filtration, purification, fluid management and lab technologies are supporting the biopharmaceutical industry around the world to develop and produce drugs safely, timely and economically. For next generation processes, Sartorius Stedim Biotech focuses on single-use technologies and value-added services to meet the rapidly changing technology requirements of the industry it serves. Strongly rooted in the scientific community and closely allied with customers and technology partners, the company is dedicated to its philosophy of "turning science into solutions" on a daily basis.

Headquartered in Aubagne, France, Sartorius Stedim Biotech is listed on the Eurolist of Euronext Paris. With its own manufacturing and R&D sites in Europe, North America and Asia and a global network of sales companies, Sartorius Stedim Biotech enjoys a worldwide presence. Its key manufacturing and R&D site is in Germany. The company employs over 2,300 people, and in 2008 generated sales revenue of 368.0 million euros.

This press release contains statements about the future development of the Sartorius Stedim Biotech Group. The content of these statements cannot be guaranteed as they are based on assumptions and estimates that harbor certain risks and uncertainties.

A Profile of ExcellGene
ExcellGene SA is one of the leading science and technology driven service providers of process development and optimization solutions to the pharma/biotech industry. It pioneers innovative technologies for production of recombinant proteins in mammalian cells, such as the CultiFlask system and orbital shake ("OrbShake") bioreactors. Moreover, ExcellGene provides services covering the entire production chain from DNA to the finished protein under cGMP conditions, using stable cell lines and transient transfection. The company is headquartered in Monthey, Switzerland. For further information about ExcellGene SA, visit www.excellgene.com.