Conclusions

The success of cell line development efforts depends in part on understanding the optimal use of the components of a given expression system and in part on the availability of adequate high-throughput methods to identify cell lines that will perform well in the context of the process. Over the past decade, developments in host cell line selection, vector technology, selection and screening strategies have combined to enable stable, high-level expression of many recombinant genes in mammalian cells for clinical and commercial supply. Since timely development of robust, highly productive cell lines is key to maximizing the efficiency of the drug development process and ultimately minimizing the cost of manufacturing, current efforts in the field are directed towards rapid, consistent generation of highly productive cell lines and genetic engineering of host cell lines to display functional attributes that improve product consistency and quality and robustness of performance in large-scale cell culture processes.

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