Toward product attribute control: developments from genome sequencing

Chinese hamster ovary (CHO) cells are important hosts for the production of therapeutic proteins. Recent genome sequencing studies provide an initial baseline of information useful for understanding cell line performance in terms of product quality attributes. However, the lack of a well-established reference genome together with concerns about genome stability have not yet permitted the community to define the detailed relationship between the genome and cell line performance. Emerging efforts to define a new reference genome, together with new data on genome stability, herald an era where cell line's with defined genomes can be combined with defined process parameters to yield product quality attribute control.