Cell line development for biomanufacturing processes

A large number of recombinant protein therapeutics like monoclonal antibodies are manufactured in animal cells because of their ability to provide appropriate post-translational modifications. Protein production using animal cells requires the development of a cell line with the gene of interest integrated into the host cell genome and stably expressing the protein of interest at an acceptable level of productivity. This chapter provides a summary of the various steps required for the development of such a cell line starting from the transfection of the gene of interest into an appropriate host cell. The identification of such a cell line currently requires the screening of a large number of single-cell clones subsequent to transfection to identify an acceptable clone. However, recent advances in molecular approaches and high-throughput screening techniques, summarized here in brief, are now allowing an increase in the success rate of identifying a suitable cell line.