ABSTRACT
Cell lines are cornerstones for viral vaccine manufacturing. Several cell lines and technology platforms were developed according the type of antigen to be produced for efficacious vaccines. Vaccine safety is highly critical. Regarding technical elements of viral vaccines, viral safety of manufacturing process including cell lines is deeply investigated and documented. Various analytical methods are used to document the quality of cell lines. New technologies are emerging to improve the cell line characterization. This chapter reviews which cell lines are useful for vaccine manufacturing, and how they are selected. The review includes information on viral safety and associated regulatory guidance; and on the analytical considerations for determining cell line quality with respect to vaccine safety.
