Strategic Approaches to Viral Safety and Viral Clearance Assessment in Cell Culture-Derived Pharmaceutical Products

by Marshall Dinowitz, ScD
Volume 2, Issue 1 (January/February 2003)

Viral safety and viral clearance evaluation are high-profile areas for product safety. Regulators are keenly focused on viral safety and expect high-quality data to support it, particularly for IND and BLA approvals. Familiarity with process and regulatory requirements, as well as expertise in the key areas of viral clearance, are essential for strategic planning and can yield savings in time, effort, and money...

Citation:
Dinowitz M. Strategic Approaches to Viral Safety and Viral Clearance Assessment in Cell Culture-Derived Pharmaceutical Products. BioProcess J, 2003; 2(1): 48-50.