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The company now offers its CONFIDENCE virus clearance services to support validation of viral clearance processes.
Sartorius Stedim Biotech has launched its CONFIDENCE virus clearance services, a new feasibility studies, design, and optimization consultancy, to provide validation support for viral clearance processes.
Through the service, Sartorius will now provide feasibility virus-spiking studies for purification technologies using, among others but not exclusively, minute virus of mice (MVM) or murine leukemia virus (MuLV). This expansion in the company’s services portfolio will be followed by the launch of good laboratory practices (GLP) virus clearance studies in the second quarter of 2021. Sartorius will use advanced chromatography technologies for all studies to remove residual protein and obtain highly purified virus stocks in high titers. The company aims to achieve and ensure robust and reliable results, Sartorius stated in a June 23, 2020 press release.
The results from Sartorius’ virus clearance service has an approximately six-week turnaround time compared to the industry’s current lead times, which can reach six months, Sartorius stated in its press release. The shorter turnaround time can contribute to an increase in the potential success of GLP study completion.
Viral contamination has been a major challenge to biologic development because it can result in significant delays as manufacturers work to remove viral contaminants during production. Before manufacturing begins, the viral clearance process must be validated to ensure patient safety and to comply with regulatory requirements.
Source: Sartorius Stedim Biotech