Production of Recombinant Therapeutic Proteins by Mammalian Cells in Suspension Culture

Abstract

AbstractWithin the past 10 yr, 17 monoclonal antibodies (MAbs) have been approved in the United States. A survey of these approved MAbs reveals that the predominant platform is a serum-free, stirred-tank mammalian cell culture. In fact, all 17 products are grown in only four cell lines: Chinese hamster ovary (CHO) cells, mouse myeloma cells (NS0 and Sp2/0), or hybridoma cells. The trend toward platform consolidation enables the possibility to quicken process development timelines to establish a common method in the development of a large-scale production process. This chapter will outline the general format for producing a recombinant protein in stirred tank, serumfree cultures beginning from a recombinant plasmid and a mammalian host cell line. Although different cell lines are used in this chapter as examples for the various methods, these methods are applicable across most common production cell lines. The purification options following harvest of the bulk material are not discussed, nor are the details of regulatory requirements, but purification information is readily available in other chapters of this book, and regulatory guidance documents are available at the regulatory websites, such as http://www.fda.gov/cber and http://www.ich.org.KeywordsShake FlaskChinese Hamster Ovary CellChinese Hamster OvaryCationic LipidCell Culture ProcessThese keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.