Viral Safety For Biopharmaceuticals: Sartorius Stedim Biotech And Bayer Technology Services Form An Alliance
GOETTINGEN, Germany & LEVERKUSEN, Germany --(Business Wire)-- Sartorius Stedim Biotech GmbH (Paris:DIM), Goettingen, and Bayer Technology Services GmbH (BTS), Leverkusen, both located in Germany, have just signed an exclusive cooperation agreement on the manufacture and worldwide marketing of UVivatec® products. With the technology developed by BTS, viruses are inactivated in biopharmaceuticals by UVC irradiation. Typical areas of use are virus inactivation of cell culture media, antibody solutions and solutions containing recombinant proteins as well as irradiation of vaccines and therapeutics produced from blood and plasma. Further areas of application, such as removal of mycoplasma from bioreactor media, are currently being assessed.
Viral safety in biopharmaceutical manufacturing processes are gaining ever-increasing importance. Already during early clinical phases, the regulatory authorities for pharmaceuticals have already mandated the manufacturers to provide at least two complementary technologies for virus clearence. By cooperating with BTS, Sartorius Stedim Biotech now has three different technological methods and thus an "orthogonal technology platform" for virus clearance: The Sartorius Virosart CPV® product removes viruses by nanofiltration, Sartobind® accomplishes this by adsorption of viruses and UVivatec® inactivates viruses by UVC irradiation. These three technologies are combinable with one another, thereby enabling an especially effective approach for removal of a broad spectrum of different viruses.
Compared with conventional methods, the proprietary UVivatec® technology is ideal for highly efficient inactivation of small non-enveloped viruses (e.g., Parvo viruses). So far, no other virus inactivation method has been able to attain this level of clearance efficiency. The UVivatec® technology is therefore especially suitable as an alternative or supplementary method for upstream and downstream processing.
The technology is scalable and marketed by Sartorius Stedim Biotech as single-use modules, laboratory bench units and process systems. Beyond this, Sartorius Stedim Biotech will soon be offering non-GLP virus studies and in collaboration with BTS further process development and engineering services, which will save customers substantial time and expense. BTS will also contribute its expertise to this partnership and actively work with Sartorius Stedim Biotech on the further advancement of this technology.
"By cooperating with Bayer Technology Services, we have now added an innovative, yet proven, technology to our portfolio, which can help significantly increase process reliability and economy in the production of many pharmaceuticals. For our customers, this creates true added value and simultaneously demonstrates that we have been consistently following our strategic approach as a total solutions provider. Through the combination of UVivatec® technology with our other products and services, we are not only strengthening our position in the biotech sector, but also in the growing market of blood products, in particular," says Reinhard Vogt, Executive Vice President of Sartorius Stedim Biotech.
Dr. Klaus Sommer, who heads Business Management and is the Senior Vice President of Bayer Technology Services, states: "We have systematically pursued the development of UVivatec® technology from the initial idea all the way to a marketable product, and have proven its potential in reference projects of renowned biopharmaceutical manufacturers. This shows our commitment to using our technological expertise for the benefit of our customers. In our alliance, we see an especially promising approach for marketing UVivatec® technology using the Sartorius Stedim Biotech platform. This cooperation gives us the opportunity to focus on extending our area of applications and on further developing our equipment technology."
In close collaboration with this cooperation agreement, Sartorius Stedim Biotech signed a purchase contract with the Belgian Red Cross on patents to use UVC technology for blood fractionation and manufacture of biotech products.
First UVivatec® reference at the Bayer HealthCare (BHC) biotechnology pilot plant in Wuppertal (Photo: Bayer Technology Services)
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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 2007 generated pro forma sales revenue of 375.9 million euros.
This press release contains statements about the future development of the Sartorius Stedim Biotech Group. We cannot guarantee that the content of these statements will actually apply because these statements are based upon assumptions and estimates that harbor certain risks and uncertainties.
A profil of Bayer Technology Service
Bayer Technology Services GmbH offers fully-integrated solutions along the life cycle of chemical/pharmaceutical plants – from development through engineering and construction to process optimization for existing plants. The Bayer subsidiary employs nearly 2,600 experts worldwide at its headquarters in Leverkusen and other German locations, as well as in regional offices in Baytown, Texas, USA; Antwerp, Belgium; Mexico City, Mexico; and Shanghai, People's Republic of China. 2007 sales totaled approximately EUR 400 million.
Additional information about Bayer Technology Services is available at www.bayertechnology.com.
This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
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