ABSTRACT
Biologicals are being increasingly used to treat and correct an array of medical conditions and metabolic dysfunctions. This chapter focuses on the virological safety of continuous cell line (CCL)-derived products, with a specific emphasis on virus removal by filtration. CCLs serve as substrates for the production of a number of biopharmaceuticals and, consequently, from a process standpoint, they constitute a manufacturing component. CCL characterization is an integral part of establishing quality control over the manufacturing process. Virus removal methods include removal by size exclusion, for example, filtration, adsorption to certain matrices, e.g., chromatography, and partitioning into a different fraction. The two major membrane filtration systems for the removal of viral particles from fluids are single pass or direct flow filtration and cross-flow or tangential flow filtration. The chapter briefly describe applications of filtration for virus removal. Filtration methodologies designed for viral removal applications will contribute significantly to the reduction of endogenous and adventitious viral contaminants.
