Biopharma Virus Clearance Studies: The Fundamentals

Learn about the fundamentals of virus clearance studies. We also introduce you to the most important aspects of conducting these studies and provide information about Sartorius Confidence® Virus Clearance Services.

Virus contamination in biopharma manufacturing can have serious clinical and economic consequences, such as loss of public confidence, time, and money. To ensure patient safety, manufacturers must apply three complementary key approaches to viral safety as defined in ICH Q5A: Selection, Reduction, and Testing. To ensure the effectiveness of the purification (virus reduction) steps virus clearance studies must be conducted.

Sartorius Confidence® Virus Clearance Services use highly purified, relevant, and model viruses, including MVM, MuLV, Reo-3, to ensure robust and reliable results. We also provide rapid turnaround—as fast as six weeks. Our small team of experts has more than 50 years of combined experience and has conducted more than 700 studies. Confidence® Virus Clearance Services is a comprehensive solution that gives you the confidence to proceed.