Cell Line Development

Cell lines suitable for stable production of recombinant proteins must be possible to scale up for commercial GMP production. In particular, the cell line should: (i) be adapted to serum-free and suspension growth conditions, (ii) be able to grow at a high rate, and (iii) have a high secretory capacity. It must also exhibit an efficient energy metabolism without excess secretion of by-products and should have well-tuned protein secretion and glycosylation machinery. Furthermore, it must be stable with respect to product quality and productivity over time, and the timelines and population doublings from gene transfection to production cell line should be as short as possible. In this chapter, we describe how such stable CHO cell lines can be developed, propose options for an optimized cell line development process and discuss host cell engineering strategies and biosafety analysis.