Cell line development is a complex process whether the goal is to produce small quantities of a specific protein for defined research studies or to generate a high expressing cell line allowing the protein to be manufactured in large amounts for preclinical research and clinical trials. See MoreChinese hamster ovary (CHO) cells and hybridomas are commonly used in industry for production of recombinant proteins and monoclonal antibodies.
One of the most important factors to consider during the generation of clones for recombinant protein production is monoclonality. Cells within a population can show measurable differences in growth characteristics, maximum cell density, and specific productivity of the recombinant protein or antibody. This heterogeneity can be a challenge to achieving optimal productivity and product quality. Advances in cell line cloning and biomanufacturing processes have created new methods for selecting stable clonal cell lines expressing recombinant proteins at high levels with greater efficiency, cost-effectiveness, and productivity.
For a comprehensive review, see Le et al. (2015) Biotechnol Lett 37(8): 1553–1564.
It is important to optimize and streamline the cell development process, from upstream to downstream process development, to minimize the cost of generating high-yielding and stable cell lines. Innovations in cell culture media design, together with genomic techniques for optimizing cell lines and improved scale-up technologies have enhanced specific productivity obtainable from selected cell lines. When implemented together with automated and high-throughput techniques, upstream optimization steps allow in-process monitoring and correction of variabilities during the production phase.See Less
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