IntroductionMammalian‐based expression systems make up more than 60% of the biopharmaceutical market, with sales exceeding 140 billion dollars in 2013. Among these systems, Chinese hamster ovary (CHO) cells account for the majority of approved products and are state of the art for the production of recombinant protein therapeutics. Large and complex‐structured biologics require human‐like post‐translational modifications in order to be non‐immunogenic and functional, a feature that is adequately fulfilled by CHO cells. On the downside, CHO cells, like all rapidly growing and immortalized cell lines, are genomically unstable, intraclonally heterogeneous, and frequently undergo genotypic variations. These lead to phenotypic instability and hence problems with respect to process reproducibility or production instability. As a consequence of such genotypic drifts, CHO cells are quasi‐diploid with a chromosome number that diverges from that of the primary Chinese hamster and with different karyotypes and modal chromosome numbers for each cell line analyzed.To overcome the heterogenic nature of CHO cells, a lot of effort is put into clone and cell line development in order to obtain a clonal cell line with advantageous growth, productivity, and stable properties. The requirement for clonality is based on the assumption that subclones are phenotypically and genetically homogenous and
Biotechnology Journal – Wiley
Published: Jan 1, 2018
Keywords: ; ; ; ;
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