Optimization, design, and validation of the virus clearance process.
As concerns about viral contamination rise, biopharmaceutical manufacturers are required to verify the effectiveness of their virus clearance processes. Sartorius's Confidence Virus Clearance Service offers consulting from experts in process design and optimization to support purification processes. By using high-purity virus stocks, we guarantee robust and reliable results, achieving a rapid turnaround time of just six weeks. This comprehensive virus clearance solution provides the "confidence" needed for your processes. Features and Benefits: ■ Evaluation of downstream unit operations for virus clearance ■ GLP testing ■ Non-GLP testing ■ High-purity virus stocks that guarantee reliable and trustworthy results ■ Time and cost savings by consolidating virus clearance products and services with a single provider ■ On-site flexibility | No need for sponsor presence
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basic information
Using the Confidence Virus Clearance Service, you can arrange immediate access to the laboratory's virus clearance testing slots. Examples of use: ■ Clinical Phase I/III trials ■ Feasibility or Design of Experiments (DoE) studies ■ Optimization of virus clearance processes ■ Changes in processes under development ■ Troubleshooting low LRV planned technology transfers (such as transfers to CDMOs) commercial revalidation tests
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Sartorius Stedim, established in 2007 through the merger of the German company Sartorius, founded in 1870, and the French company Stedim, is a pioneer in "Single-Use Technology (SUT)." As a company capable of providing comprehensive technical support to the pharmaceutical and biotechnology industries, its cutting-edge technology is highly regarded worldwide in the fields of scientific instruments and biotechnology.