Beschreibung
The important criteria for successful generation of a therapeutic protein from a recombinant cell are to obtain a cell line that maintains stability of the production process. If this is not achieved it can generate problems for process yields, effective use of time and money, and for regulatory approval of products. However, selection of a cell line, media and fed-batch process that sustain stability of production over the required time period may be difficult to achieve during development of a therapeutic protein. Studies were carried out to find the Stability of the Cell Lines in terms of cell counts and Monoclonal Antibody productivity by growing CHO cells in Low Osmolality Media and comparing their growth profiles with cells maintained in normal production media. Fed-batch trials were also carried out to test the effect of glutamine on the stability of these cells when maintained in Low Osmolality and production media. A trial to test the glucose consumption in the presence and absence of salts of copper and zinc was also performed for three different clones of CHO cell lines. An increase in cell count and antibody productivity was observed for cells in Low Osmolality Media when different fed-batch processes were carried out. Further studies will be aimed at increasing the antibody titre such that the cells are carried forward for production processes, thus enhancing process development.
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