The importance of standardised cell culture methods for the routine toxicology in pharmaceutical companies

The establishment and the use of standardised cell cultures build the basis for toxicological investigations and guarantees the comparison over years. The requirement for these investigations in vitro are mainly primary cell cultures from the target organs. The cell cultures should keep, also under long term culture conditions the organ differentiation. This will be suppor ted by new developments in the fields of cell culture media, supplements an d coating material of the cell culture dishes. Routinely, cells from toxicologically important organs like liver, kidney a nd nervous system were used in vitro. However, mechanistic investigations o f toxicological findings in vivo made the use of cell systems from other or gans like cartilage, bone, skeletal and heart muscle cells, testis eg neces sary. All cell culture systems were established and standardised to allow r epeated tests under the same conditions. The determination of characteristi c proteins or enzymes of the related organ will demonstrate the organ like quality of the cell cultures. The central question of toxicology is the risk assessment. Here, the in vit ro toxicology will provide important information by a comparison between hu man and animal cell cultures under the same conditions.