Portfolio Expansion - At the Achema 2009, the world's largest trade show for the process industry, Sartorius Stedim Biotech (SSB), a leading international supplier for the pharma and biotech industries, presented 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 (BTS) and the Swiss cell culture specialist Excellgene. The new bioreactors have been specially designed for the manufacture of monoclonal antibodies, recombinant proteins and vaccines.

So far, SSB 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 which uses rocking motion for the 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 SSBs Board of Directors, "Whatever our customers' application, we offer the best solution, both technically and economically."
Both partners of SSB are each bringing new process-optimized cell cultivation technologies, application-enhanced drive and container technology and biological evaluation of the new bioreactors into these cooperative alliances. SSB 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 BTS

The purpose of the cooperative alliance between SSB and BTS is to jointly develop the oscillating bioreactor designed by BTS into a market-ready product. In the process, Bayer Schering Pharma will be conducting the biological assessments of the bioreactors. Both partners intend to have SSB 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. SSB 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

Under the agreement signed with Excellgene, SSB will work together with this company to further develop the orbital shake bioreactor technology developed by Excellgene in cooperation with the Swiss company Adolf Kühner, 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 was on display at the 2009 Achema. 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 SSB 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 Adolf Kühner in these bioreactors.