Commercial production of recombinant erythropoietins
For the production of recombinant products from genetically engineered cells, a number of cell hosts may be used, but they generally belong to one of five categories: plant, bacterial, yeast, insect, or mammalian. Depending on the type of product that is desired, the features of that product, the intended use of the product, and the preferred method of manufacture, an appropriate host cell can be selected. With the appropriate genetic engineering, the gene of interest such as erythropoietin (EPO) can be produced by a host cell. In the case of EPO production, the sequence of amino acids, as well as the amount of glycosylation, must be correct to achieve the desired efficacy in vivo. This chapter describes one method of EPO production using cells genetically engineered to secrete recombinant human erythropoietin (rHuEPO). In this method of production, mammalian cells, which are capable of producing glycosylation forms with the desired efficacy in humans, are typically selected as hosts. The host mammalian cells secrete the rHuEPO product into the medium environment in which they are cultured, making the remainder of production a matter of separating the rHuEPO product from the cells and other components in the cell culture broth. This chapter summarizes the generation of rHuEPO-producing cell lines, the production of rHuEPO, the separation of rHuEPO from components of the cell culture broth, and the packaging of the final rHuEPO drug product.
KeywordsCell Bank Production Cell Line Recombinant Erythropoietin Roller Bottle Cell Culture Process
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