Sartorius Stedim Biotech GmbH, 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 clearance. 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, stated, "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.