The manufacturing processes of biological medicinal products are expected to be capable of removing and/or inactivating viruses, to primarily provide for adequate safety margins to patients and to thus satisfy the corresponding regulatory expectations. To achieve this goal, process segments specifically dedicated to the task of virus removal or inactivation are designed into manufacturing flows. The state of the art now includes virus removal by nanofiltration, and the more traditional low pH or (solvent-) detergent treatments are used widely, often to provide for two complementary and mechanically different means of virus clearance. Reflective of these process preferences, the virus-filtration/-inactivation session included seven case studies on virus filtration, and one each for a detergent and a low pH treatment.LAY ABSTRACT: To enhance virus clearance capacity, manufacturing processes of therapeutic proteins include process steps dedicated to virus clearance, especially virus-retentive filtration and virus inactivation. This article summarizes the current understanding of process preferences for the said process steps.
Keywords: Detergent treatment; Downstream processing; Low pH treatment; Virus inactivation; Virus-retentive filtration.
© PDA, Inc. 2018.