Developing a new biopharmaceutical and the associated cell line development implies many steps between the starting-cell and the final production-process.
During cell line development the production clone is generated by integrating the gene of interest (GOI) and a selection marker into a host cell. The next step after transfection is the cell selection and the single cell cloning (SCC), followed by the clone selection, the clone- and product characterization and finally by the process optimization.
The productivity of the later recombinant cell line depends on many process parameters. And the establishment of a stable, monoclonal production cell line is overall a very costly and time-consuming process which may take up to one year on average.